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OpenTrials
Completed

NCT Number: NCT00665743

Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

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

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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 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

Treatment and study plan

PN400

Drug

naproxen 500 mg /esomeprazole 20 mg

Naproxen

Drug

naproxen 500 mg tablet

Primary outcomes

  1. To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations

    Time frame: 72-hour PK

Secondary outcomes

  1. To evaluate the safety of the 3 treatments

    Time frame: entire study duration

Sponsors and collaborators

Lead sponsor

POZEN

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 24, 2008
Registry last updated
Jun 10, 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.

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