The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
Research Site
London, United Kingdom
Change in area under the plasma concentration-time curve (AUC) from time zero to infinity
Time frame: Pre-dose to Day 4
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 1
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 2
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 3
Number of subjects with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 4
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