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

NCT ID: NCT00676442

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

PN400 administered after meal

Group Type OTHER

PN400

Intervention Type DRUG

naproxen/esomeprazole

2

PN400 administered prior to meal

Group Type OTHER

PN400

Intervention Type DRUG

naproxen/esomeprazole

3

PN400 administered prior to meal

Group Type OTHER

PN400

Intervention Type DRUG

naproxen/esomeprazole

4

PN400 followed by fast

Group Type OTHER

PN400

Intervention Type DRUG

naproxen/esomeprazole

Interventions

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PN400

naproxen/esomeprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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POZEN

INDUSTRY

Sponsor Role lead

Responsible Party

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Pozen

Locations

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Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PN400-103

Identifier Type: -

Identifier Source: org_study_id