Official Title: “An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers”

We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Study Type: Interventional

Study Design: Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: PN400
  • naproxen 500 mg /esomeprazole 20 mg
• Drug: naproxen
  • naproxen 500 mg tablet
• Drug: naproxen
  • naproxen 500 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • PN400 (naproxen/esomeprazole)
• Active Comparator: B
  • naproxen 500 mg
• Active Comparator: C
  • naproxen 500 mg

Primary Measures

• To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
  • Time Frame: 72-hour PK
    Safety Issue?: No

Secondary Measures

• To evaluate the safety of the 3 treatments
  • Time Frame: entire study duration
    Safety Issue?: Yes

Inclusion Criteria:

• Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

• Standard exclusion criteria for a study of this nature

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/NCT00665743

Study ID Number: PN400-102

ClinicalTrials.gov Identifier: NCT00665743

Health Authority: United States: Food and Drug Administration