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
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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Treatment order : A, B, C | Drug: VIMOVO (AstraZeneca) VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment A Drug: VIMOVO (Patheon) VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment B Drug: Marketed enteric-coated naproxen formulation Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet Other Name: Treatment C |
| Experimental: 2 Treatment order : B, C, A | Drug: VIMOVO (AstraZeneca) VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment A Drug: VIMOVO (Patheon) VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment B Drug: Marketed enteric-coated naproxen formulation Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet Other Name: Treatment C |
| Experimental: 3 Treatment order : C, A, B | Drug: VIMOVO (AstraZeneca) VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment A Drug: VIMOVO (Patheon) VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment B Drug: Marketed enteric-coated naproxen formulation Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet Other Name: Treatment C |
| Experimental: 4 Treatment order : A, C, B | Drug: VIMOVO (AstraZeneca) VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment A Drug: VIMOVO (Patheon) VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment B Drug: Marketed enteric-coated naproxen formulation Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet Other Name: Treatment C |
| Experimental: 5 Treatment order : B, A, C | Drug: VIMOVO (AstraZeneca) VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment A Drug: VIMOVO (Patheon) VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment B Drug: Marketed enteric-coated naproxen formulation Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet Other Name: Treatment C |
| Experimental: 6 Treatment order : C, B, A | Drug: VIMOVO (AstraZeneca) VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment A Drug: VIMOVO (Patheon) VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole Other Name: Treatment B Drug: Marketed enteric-coated naproxen formulation Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet Other Name: Treatment C |
Contacts
Investigators
Principal Investigator
Stepehn Kanes
AstraZeneca, Wilmington, USA
