Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects
- Registration Number
- NCT01129388
- Lead Sponsor
- Sanofi
- Brief 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 either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects
Secondary Objectives:
* Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval
- Detailed Description
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 period after last dosing respect to clopidogrel treatment
* End of study: at 7 to 10 days after the last dosing
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group placebo - placebo + omeprazole Placebo Period 1: * Day 1: placebo loading dose in the morning under fasted conditions * Day 2 to Day 5: placebo in the morning under fasted conditions, once daily Period 2: * Day -5 to Day -1: omeprazole 80 mg in the evening 2 hours after dinner, once daily * Day 1: placebo loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner * Day 2 to Day 5: placebo in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily Group placebo + omeprazole placebo Placebo Period 1: * Day -5 to Day -1: omeprazole 80 mg, once daily in the evening 2 hours after dinner * Day 1: placebo loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner * Day 2 to Day 5: placebo in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily Period 2: * Day 1: placebo loading dose in the morning under fasted conditions * Day 2 to Day 5: placebo in the morning under fasted conditions, once daily Group clopidogrel - clopidogrel + omeprazole clopidogrel Period 1: * Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions * Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions, once daily Period 2: * Day -5 to Day -1: omeprazole 80 mg in the evening 2 hours after dinner, once daily * Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner * Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily Group clopidogrel - clopidogrel + omeprazole omeprazole Period 1: * Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions * Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions, once daily Period 2: * Day -5 to Day -1: omeprazole 80 mg in the evening 2 hours after dinner, once daily * Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner * Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily Group clopidogrel + omeprazole - clopidogrel clopidogrel Period 1: * Day -5 to Day -1: omeprazole 80 mgin the evening 2 hours after dinner, once daily * Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner * Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions * Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions, once daily Group placebo - placebo + omeprazole omeprazole Period 1: * Day 1: placebo loading dose in the morning under fasted conditions * Day 2 to Day 5: placebo in the morning under fasted conditions, once daily Period 2: * Day -5 to Day -1: omeprazole 80 mg in the evening 2 hours after dinner, once daily * Day 1: placebo loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner * Day 2 to Day 5: placebo in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily Group clopidogrel + omeprazole - clopidogrel omeprazole Period 1: * Day -5 to Day -1: omeprazole 80 mgin the evening 2 hours after dinner, once daily * Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner * Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions * Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions, once daily Group placebo + omeprazole placebo omeprazole Period 1: * Day -5 to Day -1: omeprazole 80 mg, once daily in the evening 2 hours after dinner * Day 1: placebo loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner * Day 2 to Day 5: placebo in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily Period 2: * Day 1: placebo loading dose in the morning under fasted conditions * Day 2 to Day 5: placebo in the morning under fasted conditions, once daily
- Primary Outcome Measures
Name Time Method Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment Day 5 of each period
- Secondary Outcome Measures
Name Time Method Maximum platelet aggregation intensity (MAI) induced by ADP 20µM after 5 days treatment Day 5 of each period Platelet Reactivity Index - Vasodilatator-stimulated phosphoprotein test (PRI - VASP) after 5 days treatment Day 5 of each period Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment Up to 24 hours postdose on Day 5 for each period Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment Up to 24 hours postdose on Day 5 for each period
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇺🇸Bridgewater, New Jersey, United States