Study evaluating effect of esomeprazole, omeprazole or lansoprazole on the pharmacodynamics (PD) and pharmacokinetics (PK) of clopidogrel

Study identifier:D9612C00034

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An open-label, randomized, 4-treatment, 3-period, crossover interaction study, evaluating the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the pharmacodynamics and the pharmacokinetics of clopidogrel in healthy volunteers

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

lansoprazole, omeprazole, esomeprazole, clopidogrel

Sex

All

Actual Enrollment

149

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 May 2010
Primary Completion Date: 01 May 2011
Study Completion Date: 01 May 2011

Study design

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria