Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects
NCT ID: NCT01129427
Last Updated: 2011-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2009-08-31
2009-11-30
Brief Summary
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* 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
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* 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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Group clopidogrel - clopidogrel + 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.
Clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
Pantoprazole
Pharmaceutical form: delayed-release tablet
Route of administration: oral
Group placebo - placebo + 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.
Placebo
Pharmaceutical form: matching tablet
Route of administration: oral
Pantoprazole
Pharmaceutical form: delayed-release tablet
Route of administration: oral
Group clopidogrel + pantoprazole - 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.
Clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
Pantoprazole
Pharmaceutical form: delayed-release tablet
Route of administration: oral
Group placebo + pantoprazole 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.
Placebo
Pharmaceutical form: matching tablet
Route of administration: oral
Pantoprazole
Pharmaceutical form: delayed-release tablet
Route of administration: oral
Interventions
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Clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
Placebo
Pharmaceutical form: matching tablet
Route of administration: oral
Pantoprazole
Pharmaceutical form: delayed-release tablet
Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
MALE
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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International Clinical Development Study Director
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Countries
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References
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Angiolillo DJ, Gibson CM, Cheng S, Ollier C, Nicolas O, Bergougnan L, Perrin L, LaCreta FP, Hurbin F, Dubar M. Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies. Clin Pharmacol Ther. 2011 Jan;89(1):65-74. doi: 10.1038/clpt.2010.219. Epub 2010 Sep 15.
Other Identifiers
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INT11374
Identifier Type: -
Identifier Source: org_study_id