Phase I study to evaluate bioavailability of naproxen as PN400 compared to naproxen as Proxen S and Naprosyn E
Study identifier:D1120C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Phase I, open-label, randomized, 3-way crossover study to assess relative bioavailability of single oral dose of naproxen as PN400 compared to naproxen as Proxen S and Naprosyn E in healthy volunteers
Medical condition
Healthy Volunteer
Phase
Phase 1
Healthy volunteers
Yes
Study drug
PN400, Naproxen (Proxen S), Naproxen (Naprosyn E)
Sex
All
Actual Enrollment
38
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Sept 2008
Primary Completion Date: 01 Dec 2008
Study Completion Date: 01 Dec 2008
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Jan 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: PN400 Oral Other Name: VIMOVO™ |
| Active Comparator: 2 | Drug: Naproxen (Proxen S) Oral Other Name: Proxen S |
| Active Comparator: 3 | Drug: Naproxen (Naprosyn E) Oral Other Name: Naprosyn E |
Contacts
Investigators
Principal Investigator
Mark Sostek
AstraZeneca
