Study Evaluating the Effect of Food on the Bioavailability of PN400 Components

An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00676442

Enrollment

Registered

2008-05-13

Start date

2008-05-31

Completion date

2008-06-30

Last updated

2008-09-05

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 effect of food on the bioavailability of the components of PN400

Interventions

DRUGPN400

naproxen/esomeprazole

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 old as well as other standard inclusion criteria for a study of this nature.

Exclusion criteria

* Standard

Design outcomes

Primary

Measure	Time frame
To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects.	72-hours

Secondary

Measure	Time frame
To assess the safety and tolerability of PN 400 under fasting and fed conditions.	entire study duration

Countries

United States

Outcome results

None listed

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