Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00665743

Enrollment

Registered

2008-04-24

Start date

2008-03-31

Completion date

2008-06-30

Last updated

2008-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Brief summary

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

Interventions

DRUGPN400

naproxen 500 mg /esomeprazole 20 mg

DRUGnaproxen

naproxen 500 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations	72-hour PK

Secondary

Measure	Time frame
To evaluate the safety of the 3 treatments	entire study duration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026