Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects
NCT ID: NCT01129414
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
72 participants
INTERVENTIONAL
2009-06-30
2009-08-31
Brief Summary
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* Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 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
Detailed Description
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* Screening: 2 to 21 days before the first dosing (clopidogrel or omeprazole)
* 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
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 + omeprazole
Period 1:
* Day 1: clopidogrel 600 mg loading dose
* Day 2 to Day 5: clopidogrel 150 mg, once daily
Period 2:
* Day -5 to Day -1: omeprazole 80 mg, once daily
* Day 1: clopidogrel 600 mg loading dose + omeprazole 80 mg concomitantly
* Day 2 to Day 5: clopidogrel 150 mg + omeprazole 80 mg concomitantly, once daily
Each intake is under fasted conditions
Clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
Omeprazole
Pharmaceutical form: delayed-release capsule
Route of administration: oral
Group placebo - placebo + omeprazole
Period 1:
* Day 1: placebo loading dose
* Day 2 to Day 5: placebo, once daily
Period 2:
* Day -5 to Day -1: omeprazole 80 mg, once daily
* Day 1: placebo loading dose + omeprazole 80 mg concomitantly
* Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily
Each intake is under fasted conditions
Placebo
Pharmaceutical form: matching tablet
Route of administration: oral
Omeprazole
Pharmaceutical form: delayed-release capsule
Route of administration: oral
Group clopidogrel + omeprazole - clopidogrel
Period 1:
* Day -5 to Day -1: omeprazole 80 mg, once daily
* Day 1: clopidogrel 600 mg loading dose + omeprazole 80 mg concomitantly
* Day 2 to Day 5: clopidogrel 150 mg + omeprazole 80 mg concomitantly, once daily
Period 2:
* Day 1: clopidogrel 600 mg loading dose
* Day 2 to Day 5: clopidogrel 150 mg, once daily
Each intake is under fasted conditions
Clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
Omeprazole
Pharmaceutical form: delayed-release capsule
Route of administration: oral
Group placebo + omeprazole placebo
Period 1:
* Day -5 to Day -1: omeprazole 80 mg, once daily
* Day 1: placebo loading dose + omeprazole 80 mg concomitantly
* Day 2 to Day 5: placebo + omeprazole 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
Omeprazole
Pharmaceutical form: delayed-release capsule
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
Omeprazole
Pharmaceutical form: delayed-release capsule
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 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
* 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.
18 Years
65 Years
ALL
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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2009-011005-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INT11208
Identifier Type: -
Identifier Source: org_study_id