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 (Patheon), 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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No locations available
| 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
