Comparison study of a new combination of 2 marketed medications (Esomeprazole and Naprosyn) versus Naprosyn alone
Study identifier:D1120C00035
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A single centre, two treatment, two period, two sequence, randomized crossover steady-state relative bioavailability study of naproxen in two tablet formulations given twice daily (PN 400 tablets containing 500 mg of naproxen plus 20 mg of esomeprazole versus Naprosyn® containing naproxen 500 mg)
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
PN400, Naprosyn
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Sept 2009
Primary Completion Date: -
Study Completion Date: 01 Oct 2009
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Pozen, Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 PN400 | Drug: PN400 500mg Naproxen and 20mg esomeprazole Other Name: VIMOVO™ |
| Active Comparator: 2 Naproxen | Drug: Naprosyn 500mg Naproxen Other Name: Naprosyn |
Contacts
Investigators
Principal Investigator
Terry Hurst
Q-Pharm Phase one unit
