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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Treatment A (Clopidogrel 9 days), at least 14 days wash-out, Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days) | Drug: Clopidogrel Clopidogrel Drug: Esomeprazole/ASA 20 mg/81 mg once daily for five days (Day 5-9) Other Name: Axanum |
| Experimental: 2 Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days), at least 14 days wash-out, Treatment A (Clopidogrel 9 days) | Drug: Clopidogrel Clopidogrel Drug: Esomeprazole/ASA 20 mg/81 mg once daily for five days (Day 5-9) Other Name: Axanum |
Contacts
Investigators
Principal Investigator
Peter Nagy
AstraZeneca
