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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Naprosyn

Drug: PN400

Study type

Interventional

Funder types

Industry

Identifiers

NCT00992381

D1120C00035

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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