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OpenTrials
Completed

NCT Number: NCT01129271

Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects

Primary objective:

* Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) in healthy subjects

Secondary objectives are to investigate the potential food effect on:

* ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel * Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated doses of clopidogrel

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office, Paris, France

Loading trial locations.

About this study

The total duration per subject is 8-9 weeks broken down as follows:

  • Screening: 2 to 21 days before the first dosing
  • Fed period: 7 days including 5 treatment days
  • Washout: at least 14 days after last dosing
  • Fasted period: 7 days including 5 treatment days
  • 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 male subjects:

  • as determined by medical history, physical examination including vital signs and clinical laboratory tests
  • with a body weight between 50kg and 95 kg and a Body Mass Index (BMI) between 18 and 30 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

Matching Placebo

Drug

Pharmaceutical form: tablet

Route of administration: oral

Primary outcomes

  1. Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment

    Time frame: Day 5 of each period

Secondary outcomes

  1. Maximum platelet aggregation intensity (MAI) induced by ADP 5µM after loading dose and high fat breakfast

    Time frame: 6 hours and 24 hours after first dosing of each period

  2. Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment

    Time frame: up to 24 hours postdose on Day 5 for each period

  3. Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment

    Time frame: up to 24 hours postdose on Day 5 for each period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Randomized, Placebo-controlled, Two-sequence, Two-period Crossover Study, to Investigate a Potential Food Effect on the Pharmacodynamic and Bioavailability of Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) in Healthy Male Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 24, 2010
Registry last updated
Dec 15, 2011

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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