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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: PN400 (Drug); Naprosyn (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Terry Hurst, Study Director, Affiliation: Q-Pharm Phase one unit
Jo Marjason, Principal Investigator, Affiliation: Q-Pharm Phase one unit

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.

Clinical Details

Official title: A Single Centre, Two Treatment, Two Period, Two Sequence, Randomized Crossover Steady-state Relative Bioavailability Study of Naproxen in Two Tablet Formulations Given Twice Daily (PN 400 Tablets Containing 500 mg of Naproxen Plus 20 mg of Esomeprazole Versus Naprosyn« Containing Naproxen 500 mg)

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: To determine the relative naproxen bioavailability of PN 400 (naproxen 500 mg plus esomeprazole 20 mg) compared to an immediate release Naprosyn® 500 mg tablet

Secondary outcome:

To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet,

Compare the adverse event profile of PN 400 with that from Naprosyn®

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Brisbane, Queensland, Australia
Additional Information

Starting date: September 2009
Last updated: January 15, 2010

Page last updated: August 23, 2015

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