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

September 4, 2008 updated by: POZEN

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
PN400 administered after meal
Drug: PN400
naproxen/esomeprazole
Other: 2
PN400 administered prior to meal
Drug: PN400
naproxen/esomeprazole
Other: 3
PN400 administered prior to meal
Drug: PN400
naproxen/esomeprazole
Other: 4
PN400 followed by fast
Drug: PN400
naproxen/esomeprazole

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 72-hours
72-hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

POZEN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 8, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 5, 2008

Last Update Submitted That Met QC Criteria

September 4, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN400-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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