Status:
COMPLETED
Influence of Rabeprazole on the Magnitude of the Antiplatelet Action of Clopidogrel
Lead Sponsor:
Janssen Cilag S.A.S.
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess, whether the administration of a proton pump inhibitor, Rabeprazole, has a negative effect on the activity of a concomitantly administered blood thinner drug. Pr...
Detailed Description
In this open-label trial (investigators and patients know, what medication is administered), participants will in the course of three different periods, receive three different combinations of study d...
Eligibility Criteria
Inclusion
- Healthy Volunteer in good health as determined by a medical history, physical examination including vital signs, and clinical laboratory test results
- Body Mass Index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg
- Non smoker or smokes \<5 cigarettes /day, at least 6 months before first study drug
- ECG, blood pressure in normal range (blood pressure measured after the subject is sitting for 5 minutes, between 90 and 140 mm Hg systolic (inclusive) and no higher than 90 mmHg diastolic)
Exclusion
- Personal or family history of coagulation or bleeding disorders
- Use of known inhibitors or inducers of CYP2C19 and CYP3A, including grape fruit juice intake
- Use of any prescription or non prescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) within 14 days prior to screening
- Known hypersensitivity to clopidogrel, rabeprazole, its excipients, omeprazole or substituted benzimidazoles
- Current clinically significant medical illness or history of clinically significant medical illness
- History of, or reason to believe a volunteer has a history of drug or alcohol abuse within the past 5 years
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00989300
Start Date
November 1 2009
End Date
March 1 2010
Last Update
September 21 2012
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