Study comparing a fixed-dose capsule of esomeprazole 40mg and LDA 325mg with free combination
Study identifier:D961FC00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-label, Randomized, Single-center, 2-stage Group Sequential Design, 2-way Crossover Bioequivalence Study Comparing a Fixed-dose Combination Capsule of Esomeprazole 40mg and Low-dose Acetylsalicylic Acid (ASA) 325mg with a Free Combination of Esomeprazole Capsule 40mg and Low-dose ASA
Medical condition
ulcers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Esomeprazole 40mg/ASA 325mg, Esomeprazole, ASA
Sex
All
Actual Enrollment
84
Study type
Interventional
Age
20 Years - 50 Years
Date
Study Start Date: 01 Apr 2008
Primary Completion Date: 01 Apr 2008
Study Completion Date: 01 Apr 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 combination capsule of Esomeprazole 40mg + ASA 325mg | Drug: Esomeprazole 40mg/ASA 325mg combination capsule, administered as a single oral dose Other Name: Nexium/Bayer Aspirin |
| Experimental: 2 Esomeprazole 40 mg capsule and ASA 325 mg tablet | Drug: Esomeprazole 40mg capsule, administered as a single dose Other Name: Nexium Drug: ASA 325mg tablet, administered as a single oral dose Other Name: Bayer aspirin |
Contacts
Investigators
Principal Investigator
Jörgen Naesdal
AstraZeneca
