A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels

Study Overview
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Brief Summary
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A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.

Detailed Description
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This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.

Official Title
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A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 500mg Alone, and Enteric-Coated Esomeprazole 20mg Alone.

Conditions
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Arthritis

Intervention / Treatment
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* Drug: PN 400
* Drug: EC naproxen plus EC esomeprazole
* Drug: EC naproxen
* Drug: EC esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control. Exclusion Criteria: Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PN 400 | Drug: PN 400<br>* A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)<br>|
| Active Comparator: 2<br>Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg) | Drug: EC naproxen plus EC esomeprazole<br>* Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)<br>* Other names: EC Naprosyn and Nexium;|
| Active Comparator: 3<br>Enteric-coated naproxen tablet (500mg) | Drug: EC naproxen<br>* Enteric-coated naproxen tablet (500mg)<br>* Other names: EC Naprosyn;|
| Active Comparator: 4<br>EC esomeprazole capsule (20mg) | Drug: EC esomeprazole<br>* Enteric-coated esomeprazole capsule (20mg)<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments |  | 12-72 hour PK assessments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments. |  | 72-hour PK assessments | 
| To evaluate the safety of each of the single-dose treatments |  | Entire study duration (48 days) |