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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01129063

PKM11086

2008-008450-22 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

32 participants in 1 patient group

Sequence clopidogrel 75 / 75 / 300 mg

Experimental group

Description:

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.

Treatment:

Drug: Clopidogrel