Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.

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Detailed Description

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A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Conditions

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Bioequivalence Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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D961S

2 way crossover

Group Type EXPERIMENTAL

D961S

Intervention Type DRUG

Oral gelatine capsule

esomeprazole + buffered acetylsalicylic acid

2 way crossover

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Oral HPMC capsule

Buffered acetylsalicylic acid

Intervention Type DRUG

Tablet

Interventions

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D961S

Oral gelatine capsule

Intervention Type DRUG

Esomeprazole

Oral HPMC capsule

Intervention Type DRUG

Buffered acetylsalicylic acid

Tablet

Intervention Type DRUG

Other Intervention Names

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Nexium® capsule 20 mg Bufferin Combination Tablet A81

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese males 20-45 years of age
* Classified as homo-EM
* Negative for HIV, Hepatitis B, Hepatitis C and syphilis
* Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
* Body weight 50-85 kg

Exclusion Criteria

* Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
* Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
* Need for concomitant medication in the study
* Past or present NSAIDs induced asthma
* History of bleeding diathesis

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes