Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects

Sanofi72 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

clopidogrelDRUG

Pharmaceutical form: tablet Route of administration: oral

Matching placeboDRUG

Pharmaceutical form: tablet Route of administration: oral

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Paris, France

Outcomes

Primary Outcomes

Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment

Time frame: Day 5 of each period

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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