The purpose of this study is to determine whether the absorption of naproxen from the PN 400 combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets (Naprosyn®), which are currently sold in Australia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
24
Research Site
Brisbane, Queensland, Australia
To determine the relative naproxen bioavailability of PN 400 (naproxen 500 mg plus esomeprazole 20 mg) compared to an immediate release Naprosyn® 500 mg tablet
Time frame: blood samples taken at various time points over 2 treatment periods of 11 days
To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet,
Time frame: Blood samples taken at various time point over 2 periods of 2 days
Compare the adverse event profile of PN 400 with that from Naprosyn®
Time frame: Adverse event reporting over 2 periods of 11 days
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