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

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Sanofi Identifier:
First received: May 21, 2010
Last updated: August 27, 2010
Last verified: August 2010

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

Condition Intervention Phase
Drug: Clopidogrel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC) [ Time Frame: Up to 48 hours postdose for each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z) [ Time Frame: Up to 48 hours postdose for each period ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SR25990

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01129063

Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: International Clinical Development Study Director Sanofi
  More Information

No publications provided

Responsible Party: International Clinical Development Study Director, sanofi-aventis Identifier: NCT01129063     History of Changes
Other Study ID Numbers: PKM11086  2008-008450-22 
Study First Received: May 21, 2010
Last Updated: August 27, 2010
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses processed this record on February 11, 2016