Study comparing Esomeprazole and ASA combined together as one capsule versus these medications taken separately
Study identifier:D961FC00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
An Open-Label, Randomized, Single-Center, 3-Way Crossover Study Comparing The Therapeutic Efficacy of a Fixed Dose Combination Capsule of Esomeprazole 20 mg And Acetylsalicylic Acid (ASA) 81 mg With Free Combinations of ASA Tablet 81 mg And Esomeprazole 20 mg as a Capsule or Tablet in Patients At Risk of Gastrointestinal Events Using Low Dose ASA for Cardiovascular Protection
Medical condition
Peptic ulcer disease
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Esomeprazole/ASA Fixed Combination, Esomeprazole, ASA
Sex
All
Actual Enrollment
30
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Nov 2009
Primary Completion Date: -
Study Completion Date: 01 Mar 2010
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 20 mg/ASA 81 mg Fixed Dose Combination Capsule | Drug: Esomeprazole/ASA Fixed Combination Capsule, oral, single dose |
| Active Comparator: 2 Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg | Drug: Esomeprazole oral, single dose Other Name: Nexium Drug: ASA Tablet, oral, single dose Other Name: Aspirin |
| Active Comparator: 3 Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg | Drug: Esomeprazole oral, single dose Other Name: Nexium Drug: ASA Tablet, oral, single dose Other Name: Aspirin |
Contacts
Investigators
Principal Investigator
TJorgen Nasdal
AstraZeneca R&D
