Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Phase 1

Completed

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

• Registration Number: NCT00692055
• Lead Sponsor: POZEN

Brief Summary

We will evaluate the bioavailability of naproxen 375 mg in two formulations

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-04
• Last Update Posted: 2008-09-05

Recruitment & Eligibility

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

Inclusion Criteria

• Healthy male or non-pregnant female subjects between 18-55 years 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
1	PN400	PN400
2	Naproxen	naproxen 375 mg

Primary Outcome Measures

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

Secondary Outcome Measures

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