Overview

Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
Summary
Primary objective: - Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects Secondary Objective: - Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Sanofi
Collaborator:
Bristol-Myers Squibb
Treatments:
Clopidogrel
Omeprazole
Ticlopidine
Criteria
Healthy subject:

- as determined by medical history, physical examination including vital signs and
clinical laboratory tests:

- with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female,
and with a Body Mass Index (BMI) between 18 and 30 kg/m²

Exclusion Criteria:

- Evidence of inherited disorder of coagulation/hemostasis functions

- Smoking more than 5 cigarettes or equivalent per day

- Abnormal hemostasis screen

- unability to abstain from intake of any drug affecting hemostasis throughout the whole
study duration

- Any contraindication to clopidogrel and/or omeprazole

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.