Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects

A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given With Omeprazole 80 mg/Day (12 Hours Apart on the Same Days) in Healthy Male and Female Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01129388

Enrollment

Registered

2010-05-24

Start date

2009-03-31

Completion date

2009-05-31

Last updated

2011-12-15

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

Conditions

Healthy

Brief summary

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 either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects Secondary Objectives: * Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval

Detailed 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 period after last dosing respect to clopidogrel treatment * End of study: at 7 to 10 days after the last dosing

Interventions

DRUGclopidogrel

Pharmaceutical form: tablet Route of administration: oral

DRUGPlacebo

Pharmaceutical form: matching tablet Route of administration: oral

DRUGomeprazole

Pharmaceutical form: delayed-release capsule Route of administration:oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment	Day 5 of each period

Secondary

Measure	Time frame
Maximum platelet aggregation intensity (MAI) induced by ADP 20µM after 5 days treatment	Day 5 of each period
Platelet Reactivity Index - Vasodilatator-stimulated phosphoprotein test (PRI - VASP) after 5 days treatment	Day 5 of each period
Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment	Up to 24 hours postdose on Day 5 for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment	Up to 24 hours postdose on Day 5 for each period

Countries

United States

Outcome results

None listed

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