Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

We will evaluate the bioavailability of naproxen 375 mg in two formulations

Completed

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Standard exclusion criteria for a study of this nature

Treatment and study plan

PN400

Drug

naproxen 375 mg / esomeprazole 20 mg

Naproxen

Drug

naproxen 375 mg

Primary outcomes

To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations

Time frame: 72-hour PK

Secondary outcomes

To evaluate the safety of the two treatments

Time frame: entire study duration

Sponsors and collaborators

Lead sponsor

POZEN

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jun 6, 2008
Registry last updated: Sep 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed