Status:
COMPLETED
A Healthy Female and Male Volunteers Aspirin Study
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
Brief Summary
This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.
Detailed 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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01448031
Start Date
November 1 2011
End Date
April 1 2012
Last Update
May 10 2012
Active Locations (1)
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1
Research Site
London, UK, United Kingdom