BE study between a capsule and a sachet formulation of D961H by pharmacodynamics in Japanese healthy male subjects

Study identifier:D961TC00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An open label, randomised, single center, 2 way crossover study to assess bioequivalence between a commercial HPMC capsule of D961H 20 mg and a pellets based sachet formulation of D961H 20 mg by pharmacodynamics (intragastric pH) after once-daily repeated oral administration in Japanese healthy male subjects

Medical condition

Gastric Ulcer

Phase

Phase 1

Healthy volunteers

Yes

Study drug

D961H sachet 20 mg, D961H HPMC capsule 20 mg

Sex

Male

Actual Enrollment

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 Oct 2013

Primary Completion Date: 01 Dec 2013

Study Completion Date: 01 Dec 2013

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2014 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy Japanese male subjects between 20 and 45 years of age
- Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
- Body weight 50-85 kg
- Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis
- Clinically normal findings at the enrolment medical examination, as judged by the investigator(s)
- Homo-EM according to the genotype of CYP2C19
- Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording
- Helicobacter pylori negative has been known by urea breath test as the volunteer panel data

Exclusion Criteria

- Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
- Past or present drug addiction or alcohol abuse
- Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention
- Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use)
- Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach
- Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation)
- Need for concomitant medication in the study
- Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor
- Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1
- Administration of any investigational product within 4 months preceding the pre-entry visit
- Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site)
- Clinical judgment by the investigator(s) that the subject should not participate in the study

Location

Research Site

Fukuoka-shi, Japan

Arms	Assigned Interventions
Experimental: D961H sachet 20 mg Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) and excipient granules filled into single-use aluminium sachets	Drug: D961H sachet 20 mg Each subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg
Other: D961H HPMC capsule 20 mg Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) in HPMC capsule	Drug: D961H HPMC capsule 20 mg Each subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg