An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic acid on the Metabolism and Effect of Clopidogrel

Study identifier:D961FC00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-label, Randomized, Single-center, 2-way Cross-over Interaction Study, Evaluating the Effect of Esomeprazole 20 mg/Acetylsalicylic acid 81 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel on Days 1 and 9 in Healthy Volunteers

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Clopidogrel, Esomeprazole/ASA

Sex

All

Actual Enrollment

58

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Nov 2010
Primary Completion Date: 01 Aug 2011
Study Completion Date: 01 Aug 2011

Study design

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

Verification:

Verified 01 Jun 2014 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria