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

Phase 1

Completed

• Conditions: Arthritis
• Interventions: Drug: EC naproxen; Drug: EC esomeprazole; Drug: PN 400; Drug: EC naproxen plus EC esomeprazole

• Registration Number: NCT00749385
• Lead Sponsor: POZEN

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-19
• Last Update Posted: 2008-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	EC naproxen	Enteric-coated naproxen tablet (500mg)
4	EC esomeprazole	EC esomeprazole capsule (20mg)
1	PN 400	PN 400
2	EC naproxen plus EC esomeprazole	Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

PPD; 🇺🇸 Austin, Texas, United States