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

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.

Study Overview

• Status: Completed
• Conditions: Bioequivalence Study
• Intervention / Treatment: Drug: D961S; Drug: Esomeprazole; Drug: Buffered acetylsalicylic acid

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

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Hakata, Fukuoka, Japan
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: D961S; 2 way crossover	Drug: D961S; Oral gelatine capsule
EXPERIMENTAL: esomeprazole + buffered acetylsalicylic acid; 2 way crossover	Drug: Esomeprazole; Oral HPMC capsule; Other Names: Nexium® capsule 20 mg; Drug: Buffered acetylsalicylic acid; Tablet; Other Names: Bufferin Combination Tablet A81

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).	All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.	Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)	All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.	Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA	All PK variables and plasma concentrations of esomeprazole, ASA and SA at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.	Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature.	Descriptive statistics will be provided for all safety variables, and the analyses will be performed according to the actual treatment. No formal comparison will be performed.	Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (ESTIMATE): December 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 9, 2012
• Last Update Submitted That Met QC Criteria: April 6, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Healthy volunteer, Japanese males, homo-EM
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Aspirin; Esomeprazole
• Other Study ID Numbers: D961SC00001