Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic acid 81 mg
Study identifier:D961FC00009
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-way Crossover Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination capsule of Esomeprazole 20 mg/Acetylsalicylic acid 81 mg
Medical condition
Effect of Food, pharmacokinetics
Phase
Phase 1
Healthy volunteers
Yes
Study drug
esomeprazole/ASA Fixed Dose Combination (FDC)
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Sept 2010
Study Completion Date: 01 Sept 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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 esomeprazole 20mg/ASA 81 mg FDC after a 10-hour fast | Drug: esomeprazole/ASA Fixed Dose Combination (FDC) esomeprazole 20 mg/ASA 81 mg oral capsule |
| Experimental: 2 esomeprazole 20mg/ASA 81 mg FDC 30 minutes after start of a high-fat, high-calorie breakfast | Drug: esomeprazole/ASA Fixed Dose Combination (FDC) esomeprazole 20 mg/ASA 81 mg oral capsule |
Contacts
Investigators
Principal Investigator
Kelli Craven
Quintiles
