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A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels

NCT ID: NCT00749385

Last Updated: 2008-12-23

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-10-31

Brief Summary

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A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.

Detailed Description

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This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.

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

PN 400

Group Type EXPERIMENTAL

PN 400

Intervention Type DRUG

A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)

2

Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)

Group Type ACTIVE_COMPARATOR

EC naproxen plus EC esomeprazole

Intervention Type DRUG

Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)

3

Enteric-coated naproxen tablet (500mg)

Group Type ACTIVE_COMPARATOR

EC naproxen

Intervention Type DRUG

Enteric-coated naproxen tablet (500mg)

4

EC esomeprazole capsule (20mg)

Group Type ACTIVE_COMPARATOR

EC esomeprazole

Intervention Type DRUG

Enteric-coated esomeprazole capsule (20mg)

Interventions

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PN 400

A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)

Intervention Type DRUG

EC naproxen plus EC esomeprazole

Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)

Intervention Type DRUG

EC naproxen

Enteric-coated naproxen tablet (500mg)

Intervention Type DRUG

EC esomeprazole

Enteric-coated esomeprazole capsule (20mg)

Intervention Type DRUG

Other Intervention Names

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EC Naprosyn and Nexium EC Naprosyn Nexium

Eligibility Criteria

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Inclusion Criteria

* Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.
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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PPD

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PN400-114

Identifier Type: -

Identifier Source: org_study_id