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

NCT00992381 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-01-18

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

PN400

500mg Naproxen and 20mg esomeprazole

DRUG

Naprosyn

500mg Naproxen

Sponsors & Collaborators

  • POZEN

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Terry Hurst · Q-Pharm Phase one unit

  • Jo Marjason · Q-Pharm Phase one unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Completion
2009-10-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992381 on ClinicalTrials.gov