Study identifier:D1691C00011
ClinicalTrials.gov identifier:NCT04856007
EudraCT identifier:N/A
CTIS identifier:N/A
A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.
Healthy Volunteer
Phase 1
Yes
Dapagliflozin/metformin XR FDC 5/500 mg, Dapagliflozin/metformin XR FDC 10/1000 mg, Dapagliflozin 5 mg + Metformin 500 mg XR, Dapagliflozin 10 mg + Metformin 1000 mg XR
All
80
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Other
Verified 01 Jun 2022 by AstraZeneca
AstraZeneca
-
To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets.
A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.
Location
Location
Suzhou, China, 215006
Arms | Assigned Interventions |
---|---|
Experimental: Dapagliflozin 5mg + Metformin 500mg XR co-administration of a single oral dose of a 5mg dapagliflozin (Forxiga® 5mg) tablet and a 500mg metformin XR (Glucophage XR®) tablet | Drug: Dapagliflozin/metformin XR FDC 5/500 mg In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence. Other Name: Xigduo XR |
Experimental: Dapagliflozin/metformin XR FDC 5/500 mg single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR subject | Drug: Dapagliflozin 5 mg + Metformin 500 mg XR In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence. Other Name: Forxiga + Glucophage XR |
Experimental: Dapagliflozin 10mg + Metformin 1000mg XR co-administration of a single oral dose of a 10mg dapagliflozin (Forxiga® 10mg) tablet and two 500mg metformin XR (Glucophage XR®) tablets | Drug: Dapagliflozin/metformin XR FDC 10/1000 mg In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence. Other Name: Xigduo XR |
Experimental: Dapagliflozin/metformin XR FDC 10/1000 mg ingle FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR | Drug: Dapagliflozin 10 mg + Metformin 1000 mg XR In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence. Other Name: Forxiga + Glucophage XR |
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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40/40 participants randomized to cohort 1 received treatment, and 39/40 randomized participants to cohort 2 received treatment. |
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Cohort 1: single dose of a 5mg dapagliflozin and 500mg metformin XR (Treatment A) followed by 7 to 14 days washout and then received single FDC tablet of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day1 in one treatment sequence (A:B). Or B:A in the other treatment sequence. The same applies in cohort 2, to 10mg dapagliflozin and two 500mg metformin XR tablets (Treatment C) followed by single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) . |
Description | |
---|---|
Cohort 1 | 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or Treatment B followed by 7 to 14 days washout and then Treatment A on Day1 in the other treatment sequence. |
Cohort 2 | 10mg dapagliflozin tablet and a two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or Treatment D followed by 7 to 14 days washout and then Treatment C on Day1 in the other treatment sequence. |
Cohort 1 | Cohort 2 | |
---|---|---|
STARTED | 40 | 40 |
COMPLETED | 39 | 39 |
NOT COMPLETED | 1 | 1 |
Adverse Event | 1 | 0 |
Subjects did not take 100% of the low-fat meal within the prescribed time | 0 | 1 |
Description | |
---|---|
Cohort 1 | 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or Treatment B followed by 7 to 14 days washout and then Treatment A on Day1 in the other treatment sequence. |
Cohort 2 | 10mg dapagliflozin tablet and a two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or Treatment D followed by 7 to 14 days washout and then Treatment C on Day1 in the other treatment sequence. |
Cohort 1 | Cohort 2 | Total | |
---|---|---|---|
Number of Participants
[units: Participants] |
40 | 39 | 79 |
Age Continuous
[1] [units: Years] Mean ± Standard Deviation |
28.8 ± 7.3 | 28.7 ± 6.3 | 28.7 ± 6.8 |
Sex: Female, Male
[2] [units: Participants] |
|||
Female | 6 | 2 | 8 |
Male | 34 | 37 | 71 |
Race/Ethnicity, Customized
[3] [units: Participants] Asian
|
40 | 39 | 79 |
Measure Type | Primary |
---|---|
Measure Name | Pharmacokinetic parameters of dapagliflozin by treatment in Cohort 1 |
Measure Description | Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast), and to infinity (AUCinf), and maximum observed plasma concentration (Cmax) of dapagliflozin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg |
Treatment A | Treatment B | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 |
Pharmacokinetic parameters of dapagliflozin by treatment in Cohort 1 [units: Plasma concentration] Geometric Mean (Geometric Coefficient of Variation) |
||
Cmax (ng/mL) | 57.54 (24.07%) | 56.06 (25.71%) |
AUClast (h*ng/mL) | 265.1 (20.30%) | 274.0 (21.33%) |
AUCinf (h*ng/mL) | 273.9 (20.77%) | 282.7 (21.39%) |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 97.31 |
90% Confidence Interval | ( 90.68 to 104.43 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of Cmax(ng/mL) of Dapagliflozin analyte in Cohort 1, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
B/A |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 102.35 |
90% Confidence Interval | ( 99.61 to 105.17 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of AUCinf(h*ng/mL) of Dapagliflozin analyte in Cohort 1, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
B/A |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 102.42 |
90% Confidence Interval | ( 99.90 to 105.00 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of AUClast(h*ng/mL) of Dapagliflozin analyte in Cohort 1, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
B/A |
Measure Type | Primary |
---|---|
Measure Name | Pharmacokinetic parameters of dapagliflozin by treatment in Cohort 2 |
Measure Description | Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast), and to infinity (AUCinf), and maximum observed plasma concentration (Cmax) of dapagliflozin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment C | Treatment D | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
39 | 39 |
Pharmacokinetic parameters of dapagliflozin by treatment in Cohort 2 [units: Plasma concentration] Geometric Mean (Geometric Coefficient of Variation) |
||
Cmax (ng/mL) | 113.9 (26.12%) | 111.9 (22.66%) |
AUClast (h*ng/mL) | 517.9 (21.36%) | 525.4 (21.31%) |
AUCinf (h*ng/mL) | 528.5 (22.08%) | 534.3 (21.63%) |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 98.40 |
90% Confidence Interval | ( 92.26 to 104.95 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of Cmax(ng/mL) of Dapagliflozin analyte in Cohort 2, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
D/C |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 101.06 |
90% Confidence Interval | ( 98.49 to 103.71 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of AUCinf(h*ng/mL) of Dapagliflozin analyte in Cohort 2, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
D/C |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 101.43 |
90% Confidence Interval | ( 98.99 to 103.92 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of AUClast(h*ng/mL) of Dapagliflozin analyte in Cohort 2, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
D/C |
Measure Type | Primary |
---|---|
Measure Name | Pharmacokinetic parameters of metformin by treatment in Cohort 1, based on exclusion criteria 2 |
Measure Description | Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast), and to infinity (AUCinf), and maximum observed plasma concentration (Cmax) of metformin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg |
Treatment A | Treatment B | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 |
Pharmacokinetic parameters of metformin by treatment in Cohort 1, based on exclusion criteria 2 [units: Plasma concentration] Geometric Mean (Geometric Coefficient of Variation) |
||
Cmax (ng/mL) | 537.5 (23.60%) | 554.6 (19.31%) |
AUClast (h*ng/mL) | 5334 (35.92%) | 5470 (28.23%) |
AUCinf (h*ng/mL) | 5538 (34.16%) | 5345 (26.59%) |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 100.85 |
90% Confidence Interval | ( 97.34 to 104.48 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of Cmax(ng/mL) of Metformin analyte in Cohort 1, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
B/A |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 96.47 |
90% Confidence Interval | ( 89.17 to 104.36 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of AUCinf(h*ng/mL) of Metformin analyte in Cohort 1, based on exclusion criteria 2 (based on Rsq adj < 0.8 or AUCextr > 20%): For the related subjects, exclude AUC(INF) of metformin from corresponding treatment over Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
B/A |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 102.07 |
90% Confidence Interval | ( 94.34 to 110.42 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of AUClast(h*ng/mL) of Metformin analyte in Cohort 1, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
B/A |
Measure Type | Primary |
---|---|
Measure Name | Pharmacokinetic parameters of metformin by treatment in Cohort 2 based on exclusion criteria 2 |
Measure Description | Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast), and to infinity (AUCinf), and maximum observed plasma concentration (Cmax) of metformin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment C | Treatment D | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
39 | 39 |
Pharmacokinetic parameters of metformin by treatment in Cohort 2 based on exclusion criteria 2 [units: Plasma concentration] Geometric Mean (Geometric Coefficient of Variation) |
||
Cmax (ng/mL) | 944.0 (22.56%) | 994.0 (22.39%) |
AUClast (h*ng/mL) | 9623 (35.44%) | 9607 (30.78%) |
AUCinf (h*ng/mL) | 9992 (35.95%) | 9802 (32.10%) |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 105.27 |
90% Confidence Interval | ( 101.40 to 109.27 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of Cmax(ng/mL) of Metformin analyte in Cohort 2, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
D/C |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 99.66 |
90% Confidence Interval | ( 92.81 to 107.01 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of AUCinf(h*ng/mL) of Metformin analyte in Cohort 2, based on exclusion criteria 2 (based on Rsq adj < 0.8 or AUCextr > 20%): For the related subjects, exclude AUC(INF) of metformin from corresponding treatment over Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
D/C |
Groups [1] | All groups |
---|---|
Method [3] | Mixed Models Analysis |
Other [5] | 99.86 |
90% Confidence Interval | ( 94.20 to 105.86 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|
Statistical comparison of AUClast(h*ng/mL) of Metformin analyte in Cohort 2, Bioequivalence analysis set | |
[3] | Other relevant information, such as adjustments or degrees of freedom: |
General linear mixed model with fixed effects for treatment, period and sequence, and random effect for subject nested within sequence was utilized. | |
[5] | Other relevant estimation information: |
D/C |
Measure Type | Secondary |
---|---|
Measure Name | Time to maximum observed plasma concentration (tmax) of dapagliflozin by treatment in Cohort 1 |
Measure Description | tmax (h) of dapagliflozin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg |
Treatment A | Treatment B | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 |
Time to maximum observed plasma concentration (tmax) of dapagliflozin by treatment in Cohort 1 [units: Plasma concentration] Median (Full Range) |
2.00 (0.50 to 4.00) | 2.00 (0.50 to 4.00) |
Measure Type | Secondary |
---|---|
Measure Name | Time to maximum observed plasma concentration (tmax) of dapagliflozin by treatment in Cohort 2 |
Measure Description | tmax (h) of dapagliflozin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment C | Treatment D | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
39 | 39 |
Time to maximum observed plasma concentration (tmax) of dapagliflozin by treatment in Cohort 2 [units: Plasma concentration] Median (Full Range) |
1.00 (0.50 to 3.02) | 2.00 (0.97 to 3.00) |
Measure Type | Secondary |
---|---|
Measure Name | Other pharmacokinetic parameters of dapagliflozin by treatment in Cohort 1 |
Measure Description | Terminal elimination rate constant (λz), half-life associated with terminal slope of a semi-logarithmic concentration-time curve (t½λz), apparent total body clearance of drug from plasma after extravascular administration (CL/F), and apparent volume of distribution following extravascular administration (Vz/F) of dapagliflozin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg |
Treatment A | Treatment B | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 |
Other pharmacokinetic parameters of dapagliflozin by treatment in Cohort 1 [units: Plasma concentration] Geometric Mean (Geometric Coefficient of Variation) |
||
lambda_z (/h) | 0.05996 (60.94%) | 0.05780 (60.75%) |
t½lambda_z(h) | 11.56 (60.94%) | 11.99 (60.75%) |
CL/F (L/h) | 18.26 (20.77%) | 17.68 (21.39%) |
Vz/F (L) | 304.5 (54.24%) | 306.0 (57.17%) |
Measure Type | Secondary |
---|---|
Measure Name | Other pharmacokinetic parameters of dapagliflozin by treatment in Cohort 2 |
Measure Description | Terminal elimination rate constant (λz), half-life associated with terminal slope of a semi-logarithmic concentration-time curve (t½λz), apparent total body clearance of drug from plasma after extravascular administration (CL/F), and apparent volume of distribution following extravascular administration (Vz/F) of dapagliflozin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment C | Treatment D | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
39 | 39 |
Other pharmacokinetic parameters of dapagliflozin by treatment in Cohort 2 [units: Plasma concentration] Geometric Mean (Geometric Coefficient of Variation) |
||
lambda_z (/h) | 0.06056 (58.29%) | 0.06448 (53.21%) |
t½lambda_z (h) | 11.44 (58.29%) | 10.75 (53.21%) |
CL/F (L/h) | 18.92 (22.08%) | 18.72 (21.63%) |
Vz/F (L) | 312.4 (53.78%) | 290.3 (51.77%) |
Measure Type | Secondary |
---|---|
Measure Name | Time to maximum observed plasma concentration (tmax) of metformin by treatment in Cohort 1 |
Measure Description | tmax (h) of metformin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg |
Treatment A | Treatment B | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 |
Time to maximum observed plasma concentration (tmax) of metformin by treatment in Cohort 1 [units: Plasma concentration] Median (Full Range) |
4.00 (3.93 to 8.00) | 4.00 (3.93 to 8.00) |
Measure Type | Secondary |
---|---|
Measure Name | Time to maximum observed plasma concentration (tmax) of metformin by treatment in Cohort 2 |
Measure Description | tmax (h) of metformin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment C | Treatment D | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
39 | 39 |
Time to maximum observed plasma concentration (tmax) of metformin by treatment in Cohort 2 [units: Plasma concentration] Median (Full Range) |
4.00 (2.00 to 8.00) | 6.00 (3.00 to 8.00) |
Measure Type | Secondary |
---|---|
Measure Name | Other pharmacokinetic parameters of metformin by treatment in Cohort 1, based on exclusion criteria 2 |
Measure Description | Terminal elimination rate constant (λz), half-life associated with terminal slope of a semi-logarithmic concentration-time curve (t½λz), apparent total body clearance of drug from plasma after extravascular administration (CL/F), and apparent volume of distribution following extravascular administration (Vz/F) of metformin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg |
Treatment A | Treatment B | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 |
Other pharmacokinetic parameters of metformin by treatment in Cohort 1, based on exclusion criteria 2 [units: Plasma concentration] Geometric Mean (Geometric Coefficient of Variation) |
||
lambda_z (/h) | 0.05860 (139.8%) | 0.07547 (87.69%) |
t½lambda_z (h) | 11.83 (139.8%) | 9.185 (87.69%) |
CL/F (L/h) | 90.28 (34.16%) | 93.54 (26.59%) |
Vz/F (L) | 1406 (103.8%) | 1239 (87.40%) |
Measure Type | Secondary |
---|---|
Measure Name | Other pharmacokinetic parameters of metformin by treatment in Cohort 2, based on exclusion criteria 2 |
Measure Description | Terminal elimination rate constant (λz), half-life associated with terminal slope of a semi-logarithmic concentration-time curve (t½λz), apparent total body clearance of drug from plasma after extravascular administration (CL/F), and apparent volume of distribution following extravascular administration (Vz/F) of metformin |
Time Frame | Pre-dose and 0.5,1,2,3,4,6,8,10,12,24 (Day2),36,48 (Day3), and 72 (Day4) hours post dose. |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
PK Analysis Set: Subjects who receive at least 1 dose of investigational product and have at least 1 post-dose PK measurement without important protocol deviations or violations thought to significantly affect the PK. |
Description | |
---|---|
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg |
Treatment C | Treatment D | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
39 | 39 |
Other pharmacokinetic parameters of metformin by treatment in Cohort 2, based on exclusion criteria 2 [units: Plasma concentration] Geometric Mean (Geometric Coefficient of Variation) |
||
lambda_z (/h) | 0.06328 (81.63%) | 0.06787 (85.82%) |
t½lambda_z (h) | 10.95 (81.63%) | 10.21 (85.82%) |
CL/F (L/h) | 100.1 (35.95%) | 102.0 (32.10%) |
Vz/F (L) | 1581 (83.89%) | 1503 (94.22%) |
Measure Type | Other Pre-specified |
---|---|
Measure Name | Haematology and clinical chemistry laboratory variables over time - SI unit - Change from baseline |
Measure Description | Baseline value is defined for each period as the most recent non-missing measurement collected before the administration of IP within that period. |
Time Frame | Day 2 and Day 4 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Safety analysis set |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg - cohort 2 |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg- cohort 2 |
Treatment A | Treatment B | Treatment C | Treatment D | |
---|---|---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 | 39 | 39 |
Haematology and clinical chemistry laboratory variables over time - SI unit - Change from baseline [units: Lab parameters] Mean (Standard Deviation) |
||||
B-Erythrocytes (10^12/L) - Day 2 | -0.019 (0.133) | 0.029 (0.185) | 0.049 (0.174) | 0.079 (0.201) |
B-Erythrocytes (10^12/L) - Day 4 | -0.035 (0.154) | 0.031 (0.173) | 0.100 (0.184) | 0.071 (0.201) |
B-Hemoglobin - Day 2 | 0.8 (4.3) | 1.4 (5.2) | 1.1 (4.6) | 2.1 (5.5) |
B-Hemoglobin - Day 4 | -0.7 (4.7) | 0.9 (4.9) | 2.8 (5.5) | 2.0 (5.2) |
B-Hematocrit (RATIO) - Day 2 | -0.003 (0.013) | -0.001 (0.015) | 0.001 (0.019) | 0.006 (0.021) |
B-Hematocrit (RATIO) - Day 4 | -0.003 (0.014) | -0.001 (0.015) | 0.007 (0.017) | 0.006 (0.018) |
S/P-Aspartate Aminotransferase (ukat/L) - Day 2 | 0.015 (0.050) | 0.029 (0.120) | 0.008 (0.081) | 0.022 (0.098) |
S/P-Aspartate Aminotransferase (ukat/L) - Day 4 | -0.009 (0.048) | -0.013 (0.066) | 0.014 (0.048) | 0.007 (0.063) |
S/P-Alanine Aminotransferase (ukat/L) - Day 2 | 0.015 (0.093) | -0.008 (0.056) | 0.037 (0.098) | 0.058 (0.159) |
S/P-Alanine Aminotransferase (ukat/L) - Day 4 | 0.049 (0.282) | -0.007 (0.076) | 0.041 (0.087) | 0.044 (0.186) |
S/P-Bilirubin (umol/L) - Day 2 | 2.43 (3.73) | 1.12 (3.88) | 3.12 (4.94) | 2.82 (4.02) |
S/P-Bilirubin (umol/L) - Day 4 | 1.99 (3.31) | 0.74 (3.94) | 2.93 (3.92) | 2.36 (4.29) |
S/P-Alkaline Phosphatase (ukat/L) - Day 2 | 0.027 (0.074) | 0.021 (0.076) | 0.027 (0.079) | 0.043 (0.062) |
S/P-Alkaline Phosphatase (ukat/L) - Day 4 | 0.004 (0.075) | 0.002 (0.084) | -0.003 (0.076) | 0.004 (0.048) |
S/P-Protein (g/L) - Day 2 | 0.83 (2.75) | 0.64 (2.50) | 1.04 (2.26) | 1.83 (2.74) |
S/P-Protein (g/L) - Day 4 | 0.82 (2.57) | 0.78 (3.02) | 1.31 (2.47) | 1.20 (2.48) |
S/P-Creatine Kinase (ukat/L) - Day 2 | -0.093 (0.578) | -0.039 (0.825) | -0.108 (0.425) | -0.227 (0.567) |
S/P-Creatine Kinase (ukat/L) - Day 4 | -0.159 (0.505) | -0.162 (0.431) | -0.174 (0.408) | -0.238 (0.657) |
S/P-Creatinine (umol/L) - Day 2 | 3.86 (4.67) | 4.96 (4.50) | 1.99 (3.23) | 3.81 (4.46) |
S/P-Creatinine (umol/L) - Day 4 | 1.30 (3.98) | 1.74 (3.56) | 1.07 (3.96) | 1.74 (4.39) |
S/P-Urea Nitrogen (mmol/L) - Day 2 | 0.18 (0.85) | -0.05 (0.54) | 0.42 (0.86) | 0.48 (0.93) |
S/P-Urea Nitrogen (mmol/L) - Day 4 | 0.14 (0.97) | -0.02 (0.52) | 0.29 (0.80) | 0.38 (0.90) |
S/P-Urate (umol/L) - Day 2 | -43.67 (28.29) | -51.39 (27.24) | -53.06 (26.27) | -50.32 (32.82) |
S/P-Urate (umol/L) - Day 4 | -29.26 (33.65) | -33.90 (28.29) | -36.31 (29.07) | -30.12 (33.58) |
S/P-Glucose (mmol/L) - Day 2 | 0.045 (0.305) | 0.056 (0.208) | -0.113 (0.314) | -0.083 (0.321) |
S/P-Glucose (mmol/L) - Day 4 | -0.007 (0.312) | 0.073 (0.206) | 0.047 (0.307) | 0.038 (0.273) |
S/P-Albumin (g/L) - Day 2 | 0.40 (1.64) | 0.20 (1.48) | 0.54 (1.35) | 1.08 (1.64) |
S/P-Albumin (g/L) - Day 4 | 0.56 (1.64) | 0.63 (1.82) | 1.15 (1.65) | 0.67 (1.67) |
Measure Type | Other Pre-specified |
---|---|
Measure Name | Vital signs over time - Change from baseline |
Measure Description | Baseline value is defined for each period as the most recent non-missing measurement collected before the administration of IP within that period. |
Time Frame | From Day 2 to Day 4, as applicable |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Safety analysis set |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg - cohort 2 |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg -cohort 2 |
Treatment A | Treatment B | Treatment C | Treatment D | |
---|---|---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 | 39 | 39 |
Vital signs over time - Change from baseline [units: Vital signs parameters] Mean (Standard Deviation) |
||||
Pulse Rate (breaths/min) - Day 2 | -1.3 (6.4) | -2.5 (5.7) | 0.1 (8.6) | -0.3 (8.0) |
Pulse Rate (breaths/min) - Day 3 | -0.3 (7.4) | -1.2 (5.8) | 2.6 (5.7) | 1.7 (7.8) |
Pulse Rate (breaths/min) - Day 4 | 2.8 (9.4) | 1.7 (7.7) | 4.6 (7.9) | 2.6 (8.7) |
Systolic Blood Pressure (mmHg) - Day 2 | -3.8 (7.4) | -3.1 (8.3) | -3.5 (8.4) | -5.0 (9.8) |
Systolic Blood Pressure (mmHg) - Day 3 | -1.4 (8.7) | -3.6 (7.4) | -2.8 (10.0) | -4.7 (10.4) |
Systolic Blood Pressure (mmHg) - Day 4 | -1.4 (7.9) | -0.9 (6.8) | -1.8 (9.7) | -2.3 (9.1) |
Diastolic Blood Pressure (mmHg) - Day 2 | -3.8 (5.7) | -2.0 (6.1) | -2.6 (6.9) | -3.4 (5.5) |
Diastolic Blood Pressure (mmHg) - Day 3 | -2.0 (4.5) | -2.1 (5.4) | -1.9 (6.2) | -2.0 (4.8) |
Diastolic Blood Pressure (mmHg) - Day 4 | 0.2 (5.9) | -1.3 (7.3) | -1.3 (6.4) | -0.3 (8.8) |
Temperature (C) - Day 2 | 0.19 (0.33) | 0.11 (0.32) | 0.05 (0.41) | -0.04 (0.46) |
Temperature (C) - Day 3 | 0.14 (0.34) | 0.07 (0.30) | -0.05 (0.51) | -0.18 (0.62) |
Temperature (C) - Day 4 | 0.07 (0.38) | 0.08 (0.25) | 0.00 (0.46) | -0.10 (0.41) |
Weight (kg) - Day 4 | -0.63 (1.19) | -0.72 (0.77) | -1.10 (0.74) | -1.03 (0.58) |
Respiratory Rate (breaths/min) - Day 2 | -0.9 (1.7) | -0.2 (2.2) | 0.2 (1.9) | 0.1 (1.7) |
Respiratory Rate (breaths/min) - Day 3 | 0.4 (2.3) | 0.3 (2.0) | 0.7 (2.4) | 0.3 (2.0) |
Respiratory Rate (breaths/min) - Day 4 | 0.3 (1.7) | 0.6 (1.9) | 0.7 (1.9) | 0.1 (2.4) |
Measure Type | Other Pre-specified |
---|---|
Measure Name | ECG variables over time - Change from baseline |
Measure Description | Baseline value is defined for each period as the most recent non-missing measurement collected before the administration of IP within that period. |
Time Frame | Day 1, 4 hr and 8 hr after dosing, and Day 4 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Safety analysis set |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg - cohort 2 |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg- cohort 2 |
Treatment A | Treatment B | Treatment C | Treatment D | |
---|---|---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 | 39 | 39 |
ECG variables over time - Change from baseline [units: ECG parameters] Mean (Standard Deviation) |
||||
ECG Mean Heart Rate (beats/min) - Day 1, 4 hr after dosing | -7.0 (9.0) | -6.4 (10.0) | -6.2 (12.1) | -4.7 (9.1) |
ECG Mean Heart Rate (beats/min) - Day 1, 8 hr after dosing | -2.4 (8.9) | -1.7 (9.1) | -2.5 (11.6) | -0.3 (9.7) |
ECG Mean Heart Rate (beats/min) - Day 4 | -4.6 (10.9) | -4.2 (10.5) | -4.6 (13.4) | -3.9 (12.2) |
PR Interval, Aggregate (msec) - Day 1, 4 hr after dosing | -0.5 (8.6) | -1.4 (11.6) | -3.1 (9.6) | -3.4 (13.6) |
PR Interval, Aggregate (msec) - Day 1, 8 hr after dosing | -0.3 (10.6) | -4.3 (9.0) | -3.7 (11.1) | -4.2 (13.8) |
PR Interval, Aggregate (msec) - Day 4 | 3.9 (9.1) | 2.7 (13.8) | 0.3 (9.7) | 1.2 (13.2) |
QRS Duration, Aggregate (msec) - Day 1, 4 hr after dosing | -1.6 (5.4) | -1.6 (7.0) | -1.8 (5.4) | -2.7 (5.5) |
QRS Duration, Aggregate (msec) - Day 1, 8 hr after dosing | 0.0 (6.2) | -1.4 (5.4) | -2.5 (6.4) | -2.0 (6.0) |
QRS Duration, Aggregate (msec) - Day 4 | 0.6 (6.9) | -0.7 (5.2) | -0.5 (6.6) | -1.3 (5.2) |
QT Interval, Aggregate (msec) - Day 1, 4 hr after dosing | 17.6 (23.9) | 13.6 (18.9) | 13.5 (22.5) | 10.3 (17.6) |
QT Interval, Aggregate (msec) - Day 1, 8 hr after dosing | 8.7 (22.0) | 2.8 (19.6) | 8.3 (21.8) | 2.1 (18.9) |
QT Interval, Aggregate (msec) - Day 4 | 13.1 (25.0) | 5.8 (20.3) | 10.1 (25.2) | 5.4 (22.0) |
QTcF Interval, Aggregate (msec) - Day 1, 4 hr after dosing | 3.7 (13.2) | 0.8 (9.9) | 1.9 (13.9) | 0.3 (10.8) |
QTcF Interval, Aggregate (msec) - Day 1, 8 hr after dosing | 5.1 (12.7) | 0.5 (11.2) | 5.1 (12.1) | 2.0 (10.2) |
QTcF Interval, Aggregate (msec) - Day 4 | 4.3 (13.5) | -1.7 (10.2) | 1.9 (12.7) | -3.2 (8.4) |
Measure Type | Other Pre-specified |
---|---|
Measure Name | Urinalysis data over time |
Measure Description | Baseline value is defined for each period as the most recent non-missing measurement collected before the administration of IP within that period. |
Time Frame | Baseline, Day 2 and Day 4 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Safety analysis set |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment B | Fixed-dose combination Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg - cohort 2 |
Treatment D | Fixed-dose combination Dapagliflozin/Metformin XR 10mg/1000mg- cohort 2 |
Treatment A | Treatment B | Treatment C | Treatment D | |
---|---|---|---|---|
Number of
Participants Analyzed [units:participants] |
40 | 39 | 39 | 39 |
Urinalysis data over time [units: Participants] |
||||
U-Protein (Arbitrary U) - Baseline | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Protein (Arbitrary U) - Day 2 | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Protein (Arbitrary U) - Day 4 | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Glucose (Arbitrary U) - Baseline | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Glucose (Arbitrary U) - Day 2 | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Glucose (Arbitrary U) - Day 4 | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Occult Blood (Arbitrary U) - Baseline | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Occult Blood (Arbitrary U) - Day 2 | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Occult Blood (Arbitrary U) - Day 4 | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Leukocyte Esterase (Arbitrary U) - Baseline | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Leukocyte Esterase (Arbitrary U) - Day 2 | ||||
Negative | ||||
Trace | ||||
Positive | ||||
U-Leukocyte Esterase (Arbitrary U) - Day 4 | ||||
Negative | ||||
Trace | ||||
Positive | ||||
Negative | 39 | 38 | 38 | 38 |
Trace | 1 | 1 | 1 | 1 |
Positive | 0 | 0 | 0 | 0 |
Time Frame | From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days. |
---|---|
Additional Description | No text entered. |
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment B | Fixed dose combination Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg - cohort 2 |
Treatment D | Fixed dose combination Dapagliflozin/Metformin XR 10mg/1000mg - cohort 2 |
Treatment A | Treatment B | Treatment C | Treatment D | |
---|---|---|---|---|
Total, serious adverse events | ||||
# participants affected / at risk | 0/40 (0.00%) | 0/39 (0.00%) | 0/39 (0.00%) | 0/39 (0.00%) |
Time Frame | From Day 1 to Day 4, in Treatment period 1 and 2, respectively. An average of 11 to 18 days. |
---|---|
Additional Description | No text entered. |
Threshold above which other adverse events are reported | 3% |
---|
Description | |
---|---|
Treatment A | Co-administration Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment B | Fixed dose combination Dapagliflozin/Metformin XR 5mg/500mg - cohort 1 |
Treatment C | Co-administration Dapagliflozin/Metformin XR 10mg/1000mg - cohort 2 |
Treatment D | Fixed dose combination Dapagliflozin/Metformin XR 10mg/1000mg - cohort 2 |
Treatment A | Treatment B | Treatment C | Treatment D | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total, other (not including serious) adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 8/40 (20.00%) | 7/39 (17.95%) | 7/39 (17.95%) | 5/39 (12.82%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cardiac disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sinus bradycardia1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 3/40 (7.50%) | 4/39 (10.26%) | 1/39 (2.56%) | 2/39 (5.13%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# events | 4 | 6 | 1 | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigations | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Bilirubin conjugated increased1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 0/40 (0.00%) | 0/39 (0.00%) | 2/39 (5.13%) | 1/39 (2.56%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# events | 0 | 0 | 2 | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigations | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Protein urine present1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 1/40 (2.50%) | 1/39 (2.56%) | 2/39 (5.13%) | 0/39 (0.00%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# events | 1 | 1 | 2 | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigations | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
White blood cells urine positive1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 5/40 (12.50%) | 2/39 (5.13%) | 2/39 (5.13%) | 2/39 (5.13%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# events | 5 | 2 | 2 | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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No text entered. |
Name/Title: | AstraZeneca Clinical Study Information Center |
Organization: | AstraZeneca |
Phone | 1-877-240-9479 |
E-mail: | [email protected] |
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