Study comparing Esomeprazole and Acetylsalicylic Acid (ASA) combined together as one capsule versus these medications taken separately
Study identifier:D961FC00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-Label, Randomized, Single-Centre, 3-Way Crossover Bioequivalence Study Comparing a Fixed Dose Combination Capsule of Esomeprazole 40 mg and Acetylsalicylic Acid 325 mg with Free Combinations of Esomeprazole Capsule 40 mg and Acetylsalicylic Acid Tablet 325 mg and Esomeprazole Tablet
Medical condition
Peptic ulcer disease
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Esomeprazole/ASA Fixed Combination, Esomeprazole - Nexium, ASA
Sex
All
Actual Enrollment
138
Study type
Interventional
Age
20 Years - 50 Years
Date
Study Start Date: 01 Sept 2009
Primary Completion Date: 01 Dec 2009
Study Completion Date: 01 Dec 2009
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 |
|---|---|
| Active Comparator: 1 Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule | Drug: Esomeprazole/ASA Fixed Combination Capsule, oral, single dose |
| Active Comparator: 2 Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg | Drug: Esomeprazole - Nexium Clinical Trial Capsule or MUPS Tablet, oral, single dose Drug: ASA Tablet, oral, single dose Other Name: Aspirin |
| Active Comparator: 3 Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg | Drug: Esomeprazole - Nexium Clinical Trial Capsule or MUPS Tablet, oral, single dose Drug: ASA Tablet, oral, single dose Other Name: Aspirin |
Contacts
Investigators
Principal Investigator
TJørgen Næsdal
AstraZeneca R&D
