Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

Phase 1

Completed

• Conditions: Arthritis
• Interventions: Drug: PN400; Drug: naproxen

• Registration Number: NCT00665743
• Lead Sponsor: POZEN

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Status Verified: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2008-06-09
• Last Update Posted: 2008-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	PN400	PN400 (naproxen/esomeprazole)
C	naproxen	naproxen 500 mg
B	naproxen	naproxen 500 mg

Primary Outcome Measures

Name	Time	Method
To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations	72-hour PK

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of the 3 treatments	entire study duration