Phase I study to evaluate bioavailability of naproxen as PN400 compared to naproxen as Naprosyn E
Study identifier:D1120C00024
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Phase I, open-label, randomized, 2-way crossover study to assess relative bioavailability of single oral dose of naproxen as PN400 compared to naproxen as Naprosyn E under fasting and fed conditions in healthy volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
PN400, Naproxen
Sex
All
Actual Enrollment
48
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 May 2009
Primary Completion Date: 01 Sept 2009
Study Completion Date: 01 Sept 2009
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability 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 |
|---|---|
| Experimental: 1 PN400 | Drug: PN400 oral tablet Other Name: VIMOVO™ |
| Active Comparator: 2 Naprosyn E | Drug: Naproxen oral tablet Other Name: Naprosyn E |
Contacts
Investigators
Principal Investigator
Mark Sostek
AstraZeneca
