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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01129271

Enrollment

Registered

2010-05-24

Start date

2009-04-30

Completion date

2009-06-30

Last updated

2011-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

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

Interventions

DRUGclopidogrel

Pharmaceutical form: tablet Route of administration: oral

DRUGMatching placebo

Pharmaceutical form: tablet Route of administration: oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment	Day 5 of each period

Secondary

Measure	Time frame
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

Countries

France, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026