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Completed

NCT Number: NCT01129427

Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects

Primary objective:

* Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with pantoprazole 80 mg/day compared to given alone in healthy male subjects * Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel is given either alone or concomitantly with pantoprazole

Secondary Objective:

* Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either alone or concomitantly with pantoprazole

Completed

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

About this study

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

  • Screening: 2 to 21 days before the first dosing
  • Period clopidogrel/placebo: 7 days including 5 days treatment
  • Period clopidogrel/placebo + pantoprazole: 14 days including 12 days treatment
  • Washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment
  • 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 subject:

  • as determined by medical history, physical examination including vital signs and clinical laboratory tests:
  • with a body weight between 50 kg and 95 kg and with 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
  • Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
  • Any contraindication to clopidogrel and/or pantoprazole

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

Placebo

Drug

Pharmaceutical form: matching tablet

Route of administration: oral

Pantoprazole

Drug

Pharmaceutical form: delayed-release tablet

Route of administration: oral

Other names: PROTONIX

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

  2. Clopidogrel active metabolite 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 of each period

Secondary outcomes

  1. Maximum platelet aggregation intensity (MAI) induced by ADP 20µM after 5 days treatment

    Time frame: Day 5 of each period

  2. Platelet Reactivity Index - Vasodilatator-stimulated phosphoprotein test (PRI - VASP) after 5 days treatment

    Time frame: Day 5 of each period

  3. Clopidogrel 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-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given Concomitantly With Pantoprazole 80 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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