Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

POZEN

Status and phase: Completed; Phase 1

Conditions: Arthritis

Treatments: Drug: naproxen; Drug: PN400

Study type: Interventional

Funder types: Industry

Identifiers

NCT00665743

PN400-102

Details and patient eligibility

About

We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature

Exclusion criteria

• Standard exclusion criteria for a study of this nature

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

A

Experimental group

Description:

PN400 (naproxen/esomeprazole)

Treatment:

Drug: PN400

B

Active Comparator group

Description:

naproxen 500 mg

Treatment:

Drug: naproxen

Drug: naproxen

C

Active Comparator group

Description:

naproxen 500 mg

Treatment:

Drug: naproxen

Drug: naproxen