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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: omeprazole; Drug: clopidogrel; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01129375

INT11146

Details and patient eligibility

About

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 omeprazole 80 mg/day compared to given alone in healthy male and female subjects

Secondary Objective:

• Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

Full description

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 + omeprazole: 12 days including 10 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

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy 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 if male, between 40 kg and 85 kg if female, 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 omeprazole

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 - clopidogrel + omeprazole

Experimental group

Description:

Period 1: * Day 1: clopidogrel 300 mg loading dose * Day 2 to Day 5: clopidogrel 75 mg, once daily Period 2: * Day -5 to Day -1: omeprazole 80 mg, once daily * Day 1: clopidogrel 300 mg loading dose + omeprazole 80 mg concomitantly * Day 2 to Day 5: clopidogrel 75 mg + omeprazole 80 mg concomitantly, once daily Each intake is under fasted conditions

Treatment:

Drug: omeprazole

Drug: clopidogrel

Group placebo - placebo + omeprazole

Placebo Comparator group

Description:

Period 1: * Day 1: placebo loading dose * Day 2 to Day 5: placebo, once daily Period 2: * Day -5 to Day -1: omeprazole 80 mg, once daily * Day 1: placebo loading dose + omeprazole 80 mg concomitantly * Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily Each intake is under fasted conditions

Treatment:

Drug: omeprazole

Drug: placebo

Group clopidogrel + omeprazole - clopidogrel

Experimental group

Description:

Period 1: * Day -5 to Day -1: omeprazole 80 mg, once daily * Day 1: clopidogrel 300 mg loading dose + omeprazole 80 mg concomitantly * Day 2 to Day 5: clopidogrel 75 mg + omeprazole 80 mg concomitantly, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose * Day 2 to Day 5: clopidogrel 75 mg, once daily Each intake is under fasted conditions

Treatment:

Drug: omeprazole

Drug: clopidogrel

Group placebo + omeprazole placebo

Placebo Comparator group

Description:

Period 1: * Day -5 to Day -1: omeprazole 80 mg, once daily * Day 1: placebo loading dose + omeprazole 80 mg concomitantly * Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily Period 2: * Day 1: placebo loading dose * Day 2 to Day 5: placebo, once daily Each intake is under fasted conditions

Treatment:

Drug: omeprazole

Drug: placebo