Influence of Rabeprazole on the Magnitude of the Antiplatelet Action of Clopidogrel

Launched by JANSSEN CILAG S.A.S. · Oct 2, 2009

Keywords

ClinConnect Summary

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 drugs, namely either clopidogrel combined with rabeprazole, or clopidogrel combined with omeprazole or clopidogrel combined with placebo. Each of these treatment periods will last 7 days and will be interrupted by 2 to 3 weeks without any medication. The goal is to recruit a total of 36 healthy volunteers for all three periods. Clopidogrel is a blood thinner drug that acts on the platelet cell m...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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