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

Arthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749385
• Other study ID #: PN400-114
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2008
• Last updated: December 19, 2008
• Start date: August 2008
• Est. completion date: October 2008

Study information

• Verified date: December 2008
• Source: POZEN
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis

Intervention

Drug:
• PN 400
A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
• EC naproxen plus EC esomeprazole
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
• EC naproxen
Enteric-coated naproxen tablet (500mg)
• EC esomeprazole
Enteric-coated esomeprazole capsule (20mg)

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
POZEN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To evaluate the safety of each of the single-dose treatments		Entire study duration (48 days)	Yes