A Healthy Female and Male Volunteers Aspirin Study

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Capsule ASA 81mg/esomeprazole 20mg

Drug: Acetylsalicylzuur Apotex Cardio

Study type

Interventional

Funder types

Industry

Identifiers

NCT01448031

D961FC00012

Details and patient eligibility

About

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

Full description

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).

Enrollment

54 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.