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

POZEN

Status and phase: Completed; Phase 1

Conditions: Arthritis

Treatments: Drug: EC naproxen plus EC esomeprazole; Drug: PN 400; Drug: EC naproxen; Drug: EC esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00749385

PN400-114

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

1

Experimental group

Description:

PN 400

Treatment:

Drug: PN 400

2

Active Comparator group

Description:

Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)

Treatment:

Drug: EC naproxen plus EC esomeprazole

3

Active Comparator group

Description:

Enteric-coated naproxen tablet (500mg)

Treatment:

Drug: EC naproxen

4

Active Comparator group

Description:

EC esomeprazole capsule (20mg)

Treatment:

Drug: EC esomeprazole