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Trial record 14 of 15 for:    PKM

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01129063
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : August 30, 2010
Bristol-Myers Squibb
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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

Condition or disease Intervention/treatment Phase
Healthy Drug: Clopidogrel Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

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 Name: SR25990

Primary Outcome Measures :
  1. 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 ]
  2. Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC) [ Time Frame: Up to 48 hours postdose for each period ]

Secondary Outcome Measures :
  1. 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 ]
  2. Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z) [ Time Frame: Up to 48 hours postdose for each period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01129063

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

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Responsible Party: International Clinical Development Study Director, sanofi-aventis Identifier: NCT01129063     History of Changes
Other Study ID Numbers: PKM11086
2008-008450-22 ( EudraCT Number )
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: August 30, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs