Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects
NCT ID: NCT01129271
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2009-04-30
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group clopidogrel fed - fasting
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
clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
Group placebo fed - fasting
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
Matching placebo
Pharmaceutical form: tablet
Route of administration: oral
Group clopidogrel fasting - fed
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
clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
group placebo fasting -fed
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
Matching placebo
Pharmaceutical form: tablet
Route of administration: oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
clopidogrel
Pharmaceutical form: tablet
Route of administration: oral
Matching placebo
Pharmaceutical form: tablet
Route of administration: oral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
International Clinical Development Study Director
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hurbin F, Boulenc X, Daskalakis N, Farenc C, Taylor T, Bonneau D, Lacreta F, Cheng S, Sultan E. Clopidogrel pharmacodynamics and pharmacokinetics in the fed and fasted state: a randomized crossover study of healthy men. J Clin Pharmacol. 2012 Oct;52(10):1506-15. doi: 10.1177/0091270011419852. Epub 2011 Nov 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALI11209
Identifier Type: -
Identifier Source: org_study_id