Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects
- Registration Number
- NCT01129427
- 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 concomitantly with pantoprazole 80 mg/day compared to given alone in healthy male subjects
* Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel is given either alone or concomitantly with pantoprazole
Secondary Objective:
* Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either alone or concomitantly with pantoprazole
- 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 + pantoprazole: 14 days including 12 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 66
Inclusion Criteria
Healthy male 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 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 pantoprazole
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 - clopidogrel + pantoprazole Clopidogrel Period 1: * Day 1: clopidogrel 300 mg loading dose * Day 2 to Day 5: clopidogrel 75 mg, once daily Period 2: * Day -7 to Day -1: pantoprazole 80 mg, once daily * Day 1: clopidogrel 300 mg loading dose + pantoprazole 80 mg concomitantly * Day 2 to Day 5: clopidogrel 75 mg + pantoprazole 80 mg concomitantly, once daily Each intake is under fasted conditions. Group placebo - placebo + pantoprazole Placebo Period 1: * Day 1: placebo loading dose * Day 2 to Day 5: placebo, once daily Period 2: * Day -7 to Day -1: pantoprazole 80 mg, once daily * Day 1: placebo loading dose + pantoprazole 80 mg concomitantly * Day 2 to Day 5: placebo + pantoprazole 80 mg concomitantly, once daily Each intake is under fasted conditions. Group placebo + pantoprazole placebo Placebo Period 1: * Day -7 to Day -1: pantoprazole 80 mg, once daily * Day 1: placebo loading dose + pantoprazole 80 mg concomitantly * Day 2 to Day 5: placebo + pantoprazole 80 mg concomitantly, once daily Period 2: * Day 1: placebo loading dose * Day 2 to Day 5: placebo, once daily Each intake is under fasted conditions. Group clopidogrel - clopidogrel + pantoprazole Pantoprazole Period 1: * Day 1: clopidogrel 300 mg loading dose * Day 2 to Day 5: clopidogrel 75 mg, once daily Period 2: * Day -7 to Day -1: pantoprazole 80 mg, once daily * Day 1: clopidogrel 300 mg loading dose + pantoprazole 80 mg concomitantly * Day 2 to Day 5: clopidogrel 75 mg + pantoprazole 80 mg concomitantly, once daily Each intake is under fasted conditions. Group clopidogrel + pantoprazole - clopidogrel Clopidogrel Period 1: * Day -7 to Day -1: pantoprazole 80 mg, once daily * Day 1: clopidogrel 300 mg loading dose + pantoprazole 80 mg concomitantly * Day 2 to Day 5: clopidogrel 75 mg + pantoprazole 80 mg concomitantly, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose * Day 2 to Day 5: clopidogrel 75 mg, once daily Each intake is under fasted conditions. Group placebo - placebo + pantoprazole Pantoprazole Period 1: * Day 1: placebo loading dose * Day 2 to Day 5: placebo, once daily Period 2: * Day -7 to Day -1: pantoprazole 80 mg, once daily * Day 1: placebo loading dose + pantoprazole 80 mg concomitantly * Day 2 to Day 5: placebo + pantoprazole 80 mg concomitantly, once daily Each intake is under fasted conditions. Group clopidogrel + pantoprazole - clopidogrel Pantoprazole Period 1: * Day -7 to Day -1: pantoprazole 80 mg, once daily * Day 1: clopidogrel 300 mg loading dose + pantoprazole 80 mg concomitantly * Day 2 to Day 5: clopidogrel 75 mg + pantoprazole 80 mg concomitantly, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose * Day 2 to Day 5: clopidogrel 75 mg, once daily Each intake is under fasted conditions. Group placebo + pantoprazole placebo Pantoprazole Period 1: * Day -7 to Day -1: pantoprazole 80 mg, once daily * Day 1: placebo loading dose + pantoprazole 80 mg concomitantly * Day 2 to Day 5: placebo + pantoprazole 80 mg concomitantly, once daily Period 2: * Day 1: placebo loading dose * Day 2 to Day 5: placebo, once daily Each intake is under fasted conditions.
- 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 Clopidogrel active metabolite 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 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 (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