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

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

Collaborators

Pozen, Inc.

Inclusion and exclusion criteria

Location

Research Site

Brisbane, Queensland, Australia

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

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1722&filename=CSR-D1120C00035.pdf
Download
CSR-D1120C00035.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

+61 2 9978 3770

Contact Backup

Q- Pharm

+61 7 3845 3704

Investigators

Principal Investigator

Terry Hurst

Q-Pharm Phase one unit