A healthy female and male volunteers aspirin study
Study identifier:D961FC00012
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product)
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Capsule ASA 81mg/esomeprazole 20mg, Acetylsalicylzuur Apotex Cardio
Sex
All
Actual Enrollment
54
Study type
Interventional
Age
20 Years - 50 Years
Date
Study Start Date: 01 Nov 2011
Primary Completion Date: 01 Apr 2012
Study Completion Date: 01 Apr 2012
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Verification:
Verified 01 Nov 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Capsule ASA 81mg/esomeprazole 20mg | Drug: Capsule ASA 81mg/esomeprazole 20mg Multiple doses administered on Day 1 to 5 |
| Active Comparator: 2 ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg | Drug: Acetylsalicylzuur Apotex Cardio Multiple doses administered on Day 1 to 5 |
Contacts
Investigators
Principal Investigator
Ronnie Beboso
BioKinetic Europe Ltd,14 Great Victoria Street,Belfast, N.Ireland,United Kingdom BT2 7BA
