Pharmacokinetic Drug Interaction Study with Dapagliflozin and Glimepiride in Healthy Subjects

Study identifier:MB102-016

ClinicalTrials.gov identifier:NCT00562250

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Pharmacokinetic Drug Interaction Study with Dapagliflozin and Glimepiride in Healthy Subjects

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Dapagliflozin, Glimepiride, Dapagliflozin + Glimepiride

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 May 2008

Primary Completion Date: 01 Aug 2008

Study Completion Date: 01 Aug 2008

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

Local Institution

Vicente Lopez, Buenos Aires, Argentina, 1602

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Dapagliflozin Tablets, Oral, 20 mg, once daily, single dose
Active Comparator: Arm 2	Drug: Glimepiride Tablets, Oral, 4 mg, once daily, single dose
Active Comparator: Arm 3	Drug: Dapagliflozin + Glimepiride Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

"There is no result for the study"

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
MB102-016 _CSR _synosis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol-Myers Squibb

Pharmacokinetic Drug Interaction Study with Dapagliflozin and Glimepiride in Healthy Subjects

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Local Institution

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

MB102-016 _CSR _synosis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator