Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects
Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects
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
The total study duration per subjects is 8 - 9 weeks broken down as follows:

 -  Screening: 2 to 21 days before the first dosing

 -  Period clopidogrel/placebo: 7 days including 5 days treatment

 -  Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment

 -  Washout between periods: at least 14 days after last dosing with respect to clopidogrel
 treatment

 -  End of study: 7 to 10 days after the last dosing
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.