Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone

A Single Centre, Two Treatment, Two Period, Two Sequence, Randomized Crossover Steady-state Relative Bioavailability Study of Naproxen in Two Tablet Formulations Given Twice Daily (PN 400 Tablets Containing 500 mg of Naproxen Plus 20 mg of Esomeprazole Versus Naprosyn® Containing Naproxen 500 mg)

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.

Inclusion Criteria:

• Subjects must have a body weight greater than 50 kg and BMI within the range 18-30(inclusive).
• Subjects must be in good health, as assessed during pre-study medical examination and by review of screening results
• Subjects must understand the procedures involved and agree to participate in the study by giving fully informed, written consent

Exclusion Criteria:

• Significant intercurrent disease of any type, in particular liver, kidney, cardiovascular disease, any form of diabetes or significant gastrointestinal disorder which could affect drug absorption, or any history of gastric or duodenal ulceration.
• Ingestion of any naproxen, omeprazole, esomeprazole or related drugs prior to the recruitment interview, such that these drugs will have been ingested in the 4 weeks prior to the day set for the first Period 1 dose