Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects
- Registration Number
- NCT01129271
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective:
* Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) in healthy subjects
Secondary objectives are to investigate the potential food effect on:
* ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel
* Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated doses of clopidogrel
- Detailed Description
The total duration per subject is 8-9 weeks broken down as follows:
* Screening: 2 to 21 days before the first dosing
* Fed period: 7 days including 5 treatment days
* Washout: at least 14 days after last dosing
* Fasted period: 7 days including 5 treatment days
* End of study: 7 to 10 days after the last dosing
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
Healthy male subjects:
- as determined by medical history, physical examination including vital signs and clinical laboratory tests
- with a body weight between 50kg and 95 kg and a Body Mass Index (BMI) between 18 and 30 kg/m2
- Evidence of inherited disorder of coagulation/hemostasis functions
- Smoking more than 5 cigarettes or equivalent per day
- Abnormal hemostasis screen
- Any contraindication to clopidogrel
- Unability to abstain from intake of any drug affecting haemostasis throughout the whole study duration
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 clopidogrel fed - fasting clopidogrel Period 1: * Day 1: clopidogrel 300 mg loading dose with high fat breakfast * Day 2 to Day 5: clopidogrel 75 mg/day with standard breakfast, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose under fasted conditions * Day 2 to Day 5: clopidogrel 75 mg/day under fasted conditions, once daily Group placebo fed - fasting Matching placebo Period 1: * Day 1: placebo loading dose with high fat breakfast * Day 2 to Day 5: placebo with standard breakfast, once daily Period 2: * Day 1: placebo loading dose under fasted conditions * Day 2 to Day 5: placebo under fasted conditions, once daily group placebo fasting -fed Matching placebo Period 1: * Day 1: placebo loading dose under fasted conditions * Day 2 to Day 5: placebo in fasted conditions, once daily Period 2: * Day 1: placebo loading dose with high fat breakfast * Day 2 to Day 5: placebo with standard breakfast, once daily Group clopidogrel fasting - fed clopidogrel Period 1: * Day 1: clopidogrel 300 mg loading dose under fasted conditions * Day 2 to Day 5: clopidogrel 75 mg/day under fasted conditions, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose with high fat breakfast * Day 2 to Day 5: clopidogrel 75 mg/day with standard breakfast, 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 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 Maximum platelet aggregation intensity (MAI) induced by ADP 5µM after loading dose and high fat breakfast 6 hours and 24 hours after first dosing of 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
🇫🇷Paris, France