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OpenTrials
Completed

NCT Number: NCT00676442

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

We will evaluate the effect of food on the bioavailability of the components of PN400

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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 old 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/esomeprazole

Primary outcomes

  1. 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.

    Time frame: 72-hours

Secondary outcomes

  1. To assess the safety and tolerability of PN 400 under fasting and fed conditions.

    Time frame: entire study duration

Sponsors and collaborators

Lead sponsor

POZEN

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 13, 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.

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