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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01129063
First received: May 21, 2010
Last updated: August 27, 2010
Last verified: August 2010
  Purpose

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
Healthy
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
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129063

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

No publications provided

Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov 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:
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014