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Completed

NCT Number: NCT01494402

Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) 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.

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Key information

Conditions

Bioequivalence Study

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Study site

Hakata, Fukuoka, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D961S

Drug

Oral gelatine capsule

Esomeprazole

Drug

Oral HPMC capsule

Other names: Nexium® capsule 20 mg

Buffered acetylsalicylic acid

Drug

Tablet

Other names: Bufferin Combination Tablet A81

Primary outcomes

  1. 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

    All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.

  2. 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

    All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.

Secondary outcomes

  1. 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

    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.

  2. 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)

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 19, 2011
Registry last updated
Apr 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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