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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Bioequivalence Study

Treatments: Drug: D961S; Drug: Buffered acetylsalicylic acid; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01494402

D961SC00001

Details and patient eligibility

About

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.

Full 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 Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Enrollment: 77 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

D961S

Experimental group

Description:

2 way crossover

Treatment:

Drug: D961S

esomeprazole + buffered acetylsalicylic acid

Experimental group

Description:

2 way crossover

Treatment:

Drug: Esomeprazole

Drug: Buffered acetylsalicylic acid