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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01494402
First received: December 15, 2011
Last updated: April 6, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Bioequivalence Study
Drug: D961S
Drug: Esomeprazole
Drug: Buffered acetylsalicylic acid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ). [ Time Frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6 ] [ Designated as safety issue: No ]
    All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.

  • Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss) [ Time Frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6 ] [ Designated as safety issue: No ]
    All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.


Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6 ] [ Designated as safety issue: No ]
    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.

  • 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. [ Time Frame: Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 77
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494402

Locations
Japan
Study site
Hakata, Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01494402     History of Changes
Other Study ID Numbers: D961SC00001
Study First Received: December 15, 2011
Last Updated: April 6, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Healthy volunteer, Japanese males, homo-EM

Additional relevant MeSH terms:
Esomeprazole
Aspirin
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014