This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between
Esomeprazole and Aspirin after multiple dose administration.
Drug: Capsule ASA 81mg/esomeprazole 20mg
Drug: Acetylsalicylzuur Apotex Cardio
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Full eligibility criteria for NCT01448031
Ages eligible for Study
20 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01448031
United Kingdom (1)
London, UK, United Kingdom
View full eligibility
Tris trial is registered with FDA with number: NCT01448031. The sponsor of the trial is AstraZeneca and it is looking for 54 volunteers for the current phase.
Official trial title: 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)
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