Status:
COMPLETED
Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Bioequivalence Study
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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, esom...
Detailed Description
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 Fr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01494402
Start Date
January 1 2012
End Date
March 1 2012
Last Update
April 9 2012
Active Locations (1)
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1
Study site
Hakata, Fukuoka, Japan