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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Matching placebo; Drug: clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01129271

ALI11209

Details and patient eligibility

About

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

Full description

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

Enrollment: 72 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

72 participants in 4 patient groups, including a placebo group

Group clopidogrel fed - fasting

Experimental group

Description:

Period 1: * Day 1: clopidogrel 300 mg loading dose with high fat breakfast * Day 2 to Day 5: clopidogrel 75 mg/day with standard breakfast, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose under fasted conditions * Day 2 to Day 5: clopidogrel 75 mg/day under fasted conditions, once daily

Treatment:

Drug: clopidogrel

Group placebo fed - fasting

Placebo Comparator group

Description:

Period 1: * Day 1: placebo loading dose with high fat breakfast * Day 2 to Day 5: placebo with standard breakfast, once daily Period 2: * Day 1: placebo loading dose under fasted conditions * Day 2 to Day 5: placebo under fasted conditions, once daily

Treatment:

Drug: Matching placebo

Group clopidogrel fasting - fed

Experimental group

Description:

Period 1: * Day 1: clopidogrel 300 mg loading dose under fasted conditions * Day 2 to Day 5: clopidogrel 75 mg/day under fasted conditions, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose with high fat breakfast * Day 2 to Day 5: clopidogrel 75 mg/day with standard breakfast, once daily

Treatment:

Drug: clopidogrel

group placebo fasting -fed

Placebo Comparator group

Description:

Period 1: * Day 1: placebo loading dose under fasted conditions * Day 2 to Day 5: placebo in fasted conditions, once daily Period 2: * Day 1: placebo loading dose with high fat breakfast * Day 2 to Day 5: placebo with standard breakfast, once daily

Treatment:

Drug: Matching placebo