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

April 6, 2012 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
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.
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)
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.
Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
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.
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.
Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D961SC00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bioequivalence Study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings