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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01129063

Enrollment

Registered

2010-05-24

Start date

2009-03-31

Completion date

2009-05-31

Last updated

2010-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

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

Interventions

DRUGClopidogrel

Pharmaceutical form : tablet Route of administration: oral

Study design

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))	Up to 48 hours postdose for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC)	Up to 48 hours postdose for each period

Secondary

Measure	Time frame
Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z))	Up to 48 hours postdose for each period
Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z)	Up to 48 hours postdose for each period

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026