Official Title: “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.”

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

Study Type: Interventional

Study Design: Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: October 2008

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.

Intervention(s) in this Clinical Trial

• Drug: PN 400
  • A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
• Drug: EC naproxen plus EC esomeprazole
  • Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
• Drug: EC naproxen
  • Enteric-coated naproxen tablet (500mg)
• Drug: EC esomeprazole
  • Enteric-coated esomeprazole capsule (20mg)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • PN 400
• Active Comparator: 2
  • Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)
• Active Comparator: 3
  • Enteric-coated naproxen tablet (500mg)
• Active Comparator: 4
  • EC esomeprazole capsule (20mg)

Primary Measures

• 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
  • Time Frame: 12-72 hour PK assessments
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 72-hour PK assessments
    Safety Issue?: No
• To evaluate the safety of each of the single-dose treatments
  • Time Frame: Entire study duration (48 days)
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pozen

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00749385

Study ID Number: PN400-114

ClinicalTrials.gov Identifier: NCT00749385

Health Authority: United States: Food and Drug Administration