Status:
COMPLETED
Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg
Lead Sponsor:
AstraZeneca
Conditions:
Effect of Food
Pharmacokinetics
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to investigate the effects of food, in comparison to fasting conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and esomeprazole.
Eligibility Criteria
Inclusion
- Healthy adults who provide informed consent prior to any study-related procedures. Females must be of non-child bearing potential.
- Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
- No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.
Exclusion
- Recent history of any clinically significant illness as judged by the Investigator within two weeks prior to enrolling in the study
- History of heart, kidney, liver. or gastrointestinal disease considered to be significant as judged by the Investigator
- Moderate to heavy smoking or other nicotine use (greater than 10 cigarettes per day or corresponding amount of nicotine)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01163630
Start Date
June 1 2010
End Date
September 1 2010
Last Update
December 7 2010
Active Locations (1)
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1
Research Site
Oveland Park, Kansas, United States