Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

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The aim of this study is to determine if there is a pharmacological interaction between clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this possible interaction would change over time.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

lansoprazole 60 mg + clopidogrel 300 mg/ 75 mg

Group Type EXPERIMENTAL

lansoprazole

Intervention Type DRUG

60 mg (2x30-mg capsule), once daily

clopidogrel

Intervention Type DRUG

300 mg loading dose on Day 1 then 75 mg daily for 28 days

2

omeprazole 80 mg + clopidogrel 300/75 mg

Group Type EXPERIMENTAL

omeprazole

Intervention Type DRUG

80 mg (2x40-mg capsule), once daily

clopidogrel

Intervention Type DRUG

300 mg loading dose on Day 1 then 75 mg daily for 28 days

3

esomeprazole 40 mg + clopidogrel 300/75 mg

Group Type EXPERIMENTAL

esomeprazole

Intervention Type DRUG

40 mg (1x40-mg capsule), once daily

clopidogrel

Intervention Type DRUG

300 mg loading dose on Day 1 then 75 mg daily for 28 days

4

clopidogrel 300/75 mg alone

Group Type EXPERIMENTAL

clopidogrel

Intervention Type DRUG

300 mg loading dose on Day 1 then 75 mg daily for 28 days

Interventions

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lansoprazole

60 mg (2x30-mg capsule), once daily

Intervention Type DRUG

omeprazole

80 mg (2x40-mg capsule), once daily

Intervention Type DRUG

esomeprazole

40 mg (1x40-mg capsule), once daily

Intervention Type DRUG

clopidogrel

300 mg loading dose on Day 1 then 75 mg daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males within the age of 18-45 years and females within the age of 18-55 years with suitable veins for cannulation or repeated vein puncture. Females must be of non-childbearing potential.
* Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
* No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in study.
* History or presence of gastrointestinal e.g. GI ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
* Any clinically significant illness within 4 weeks of the first administration of investigational product. Any medical/surgical procedure or trauma within 3 months of the treatment period; scheduled surgery, including dental surgery within 2 weeks.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes