Study identifier:D961SC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Bioequivalence study
Phase 1
Yes
D961S, Esomeprazole, Buffered acetylsalicylic acid
Male
77
Interventional
20 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Nov 2013 by AstraZeneca
AstraZeneca
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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.
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
Location
Location
Hakata, Fukuoka, Japan
Arms | Assigned Interventions |
---|---|
Experimental: D961S 2 way crossover | Drug: D961S Oral gelatine capsule |
Experimental: esomeprazole + buffered acetylsalicylic acid 2 way crossover | Drug: Esomeprazole Oral HPMC capsule Other Name: Nexium® capsule 20 mg Drug: Buffered acetylsalicylic acid Tablet Other Name: Bufferin Combination Tablet A81 |
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