A Healthy Female and Male Volunteers Aspirin Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-04-30

Brief Summary

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This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.

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Detailed Description

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A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Capsule ASA 81mg/esomeprazole 20mg

Group Type EXPERIMENTAL

Capsule ASA 81mg/esomeprazole 20mg

Intervention Type DRUG

Multiple doses administered on Day 1 to 5

2

ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg

Group Type ACTIVE_COMPARATOR

Acetylsalicylzuur Apotex Cardio

Intervention Type DRUG

Multiple doses administered on Day 1 to 5

Interventions

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Capsule ASA 81mg/esomeprazole 20mg

Multiple doses administered on Day 1 to 5

Intervention Type DRUG

Acetylsalicylzuur Apotex Cardio

Multiple doses administered on Day 1 to 5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects aged 20 to 50 years inclusive.
* Have a body body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and weigh 50.0 to 100.0 kg inclusive.
* Females must be of non-childbearing potential or be of childbearing potential but have a negative serum hCG pregnancy test during screening and on admission.

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study.
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator.
* History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes