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CompletedNCT01129063Updated Aug 30, 2010

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

A Phase 1 interventional study of Clopidogrel in Healthy, sponsored by Sanofi. Completed at 1 site in France. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-30.

Sponsored by Sanofi · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Ages
18 Years to 55 Years
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

Interventions

  • DrugClopidogrel

    Pharmaceutical form : tablet Route of administration: oral

    Also known as: SR25990

06

What researchers measure

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

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Paris, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01129063
Lead sponsor
Sanofi
Collaborators
Bristol-Myers Squibb
First posted
May 24, 2010
Start date
Mar 2009
Primary completion
May 2009
Completion
May 2009
Last update
Aug 30, 2010

Study contacts

International Clinical Development Study Director
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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