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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Clopidogrel

• Registration Number: NCT01129063
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2009-03
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-27
• Last Update Posted: 2010-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence clopidogrel 75 / 75 / 300 mg	Clopidogrel	Period 1: clopidogrel 75 mg single dose Period 2: clopidogrel 75 mg single dose Period 3: clopidogrel 300 mg single dose Each intake is at around 8:00 AM under fasted conditions.

Primary Outcome Measures

Name	Time	Method
Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))	Up to 48 hours postdose for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC)	Up to 48 hours postdose for each period

Secondary Outcome Measures

Name	Time	Method
Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z))	Up to 48 hours postdose for each period
Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z)	Up to 48 hours postdose for each period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇫🇷 Paris, France