Status:
COMPLETED
An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.
Eligibility Criteria
Inclusion
- Male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years inclusive) healthy volunteers
- Female healthy volunteers must be of non-childbearing potential or be of childbearing potential, be non-lactating and have a negative pregnancy test during the pre-entry visit and be using 1 clinically accepted method of contraception
- Have a body mass index between 19 and 30 kg/m2 inclusive
- No clinically significant abnormal findings at the physical examination as judged by the investigator
Exclusion
- Any clinically significant abnormalities in laboratory screening results as judged by investigator
- Platelet count \<150 x 10\^9/L on Day -1 or any other conditions that would increase the risk of bleeding
- Previous bone marrow transplant
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01210339
Start Date
November 1 2010
End Date
August 1 2011
Last Update
October 7 2011
Active Locations (1)
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1
Research Site
Uppsala, Sweden