Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone

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

2009-09-30

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to determine whether the absorption of naproxen from the PN 400 combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets (Naprosyn®), which are currently sold in Australia.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

PN400

Group Type EXPERIMENTAL

PN400

Intervention Type DRUG

500mg Naproxen and 20mg esomeprazole

2

Naproxen

Group Type ACTIVE_COMPARATOR

Naprosyn

Intervention Type DRUG

500mg Naproxen

Interventions

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PN400

500mg Naproxen and 20mg esomeprazole

Intervention Type DRUG

Naprosyn

500mg Naproxen

Intervention Type DRUG

Other Intervention Names

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VIMOVO™

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a body weight greater than 50 kg and BMI within the range 18-30(inclusive).
* Subjects must be in good health, as assessed during pre-study medical examination and by review of screening results
* Subjects must understand the procedures involved and agree to participate in the study by giving fully informed, written consent

Exclusion Criteria

* Significant intercurrent disease of any type, in particular liver, kidney, cardiovascular disease, any form of diabetes or significant gastrointestinal disorder which could affect drug absorption, or any history of gastric or duodenal ulceration.
* Ingestion of any naproxen, omeprazole, esomeprazole or related drugs prior to the recruitment interview, such that these drugs will have been ingested in the 4 weeks prior to the day set for the first Period 1 dose

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes