A Healthy Female and Male Volunteers Aspirin Study

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)

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

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).

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.