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OpenTrials
Completed

NCT Number: NCT01129063

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office

Paris, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel

Drug

Pharmaceutical form : tablet

Route of administration: oral

Other names: SR25990

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 24, 2010
Registry last updated
Aug 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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