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

An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence clopidogrel 75 / 75 / 300 mg; 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.	Drug: Clopidogrel; Pharmaceutical form : tablet Route of administration: oral; Other Names: SR25990

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: May 21, 2010
• First Submitted That Met QC Criteria: May 21, 2010
• First Posted (Estimate): May 24, 2010

Study Record Updates

• Last Update Posted (Estimate): August 30, 2010
• Last Update Submitted That Met QC Criteria: August 27, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: PKM11086; 2008-008450-22 (EudraCT Number)