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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: PN400
* Drug: Naprosyn


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PN400 | Drug: PN400<br>* 500mg Naproxen and 20mg esomeprazole<br>* Other names: VIMOVO™;|
| Active Comparator: 2<br>Naproxen | Drug: Naprosyn<br>* 500mg Naproxen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | blood samples taken at various time points over 2 treatment periods of 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet, |  | 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® |  | Adverse event reporting over 2 periods of 11 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GI Pain, healthy participants, Safety, bioavailability