NCT00749385

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Arthritis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-09-09
• Last updated: 2008-12-23

Locations

1 site across 1 country: United States