A bioequivalence study to compare VIMOVO manufactured at AstraZenca AB to VIMOVO manufactured by Patheon Pharmaceuticals and marketed enteric-coated Naproxen formulation

Study identifier:D1120C00030

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers

Medical condition

Healthy Volunteers, bioequivalence

Phase

Phase 1

Healthy volunteers

Yes

Study drug

VIMOVO (AstraZeneca), VIMOVO (AstraZeneca), VIMOVO (AstraZeneca), VIMOVO (AstraZeneca), VIMOVO (AstraZeneca), VIMOVO (AstraZeneca), VIMOVO (Patheon), VIMOVO (Patheon), VIMOVO (Patheon), VIMOVO (Patheon), VIMOVO (Patheon), VIMOVO (Patheon), Marketed enteric-coated naproxen formulation, Marketed enteric-coated naproxen formulation, Marketed enteric-coated naproxen formulation, Marketed enteric-coated naproxen formulation, Marketed enteric-coated naproxen formulation, Marketed enteric-coated naproxen formulation

Sex

All

Actual enrollment

36

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Sept 2011
Primary Completion Date: 01 Oct 2011
Study Completion Date: 01 Oct 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria