Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects
December 14, 2011 updated by: Sanofi
A Randomized, Placebo-controlled, Two-sequence, Two-period Crossover Study, to Investigate a Potential Food Effect on the Pharmacodynamic and Bioavailability of Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) in Healthy Male Subjects
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France
- Sanofi-Aventis Administrative Office
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group clopidogrel fed - fasting
Period 1:
Period 2:
|
Pharmaceutical form: tablet Route of administration: oral |
|
Placebo Comparator: Group placebo fed - fasting
Period 1:
Period 2:
|
Pharmaceutical form: tablet Route of administration: oral |
|
Experimental: Group clopidogrel fasting - fed
Period 1:
Period 2:
|
Pharmaceutical form: tablet Route of administration: oral |
|
Placebo Comparator: group placebo fasting -fed
Period 1:
Period 2:
|
Pharmaceutical form: tablet Route of administration: oral |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
Time Frame: Day 5 of each period
|
Day 5 of each period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximum platelet aggregation intensity (MAI) induced by ADP 5µM after loading dose and high fat breakfast
Time Frame: 6 hours and 24 hours after first dosing of each period
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6 hours and 24 hours after first dosing of each period
|
|
Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment
Time Frame: up to 24 hours postdose on Day 5 for each period
|
up to 24 hours postdose on Day 5 for each period
|
|
Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment
Time Frame: up to 24 hours postdose on Day 5 for each period
|
up to 24 hours postdose on Day 5 for each period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
May 21, 2010
First Submitted That Met QC Criteria
May 21, 2010
First Posted (Estimate)
May 24, 2010
Study Record Updates
Last Update Posted (Estimate)
December 15, 2011
Last Update Submitted That Met QC Criteria
December 14, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALI11209
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.