Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects
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
1 other identifier
interventional
72
2 countries
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Apr 2009
Shorter than P25 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedDecember 15, 2011
December 1, 2011
2 months
May 21, 2010
December 14, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
Day 5 of each period
Secondary Outcomes (3)
Maximum platelet aggregation intensity (MAI) induced by ADP 5µM after loading dose and high fat breakfast
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
up to 24 hours postdose on Day 5 for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment
up to 24 hours postdose on Day 5 for each period
Study Arms (4)
Group clopidogrel fed - fasting
EXPERIMENTALPeriod 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
Group placebo fed - fasting
PLACEBO COMPARATORPeriod 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
Group clopidogrel fasting - fed
EXPERIMENTALPeriod 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
group placebo fasting -fed
PLACEBO COMPARATORPeriod 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
Interventions
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Bristol-Myers Squibbcollaborator
Study Sites (2)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
Sanofi-Aventis Administrative Office
Paris, France
Related Publications (1)
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.
PMID: 22128201RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
International Clinical Development Study Director
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 24, 2010
Study Start
April 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
December 15, 2011
Record last verified: 2011-12