Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects

Sanofi32 enrolled

Overview

The objectives of the study are to: * Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects * Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel

The total study duration per subject is 4 - 6 weeks broken down as follows: * Screening: 2 to 21 days before the first dosing * Period 1, 2 and 3: 4 days including 1 treatment day each * Washout between periods: at least 7 days between 2 administrations * End of study: 7 to 10 days after the last dosing

Study Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ClopidogrelDRUG

Pharmaceutical form : tablet Route of administration: oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Healthy subjects: * as determined by medical history and complete physical examination including vital signs and clinical laboratory tests * with a body weight between 50kg and 95 kg if male, between 40.0 kg and 85.0 kg if female and a Body Mass Index (BMI) between 18 and 28 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 (1)

Sanofi-Aventis Administrative Office

Paris, France

Outcomes

Primary Outcomes

Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))

Time frame: Up to 48 hours postdose for each period

Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC)

Time frame: Up to 48 hours postdose for each period

Secondary Outcomes

Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z))

Time frame: Up to 48 hours postdose for each period

Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z)

Time frame: Up to 48 hours postdose for each period

Data from ClinicalTrials.gov

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