Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: PN400 (Drug); Naprosyn (Drug)
Phase: Phase 1
Status: Recruiting
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
Overall contact:
AstraZeneca Clinical Study Information, Phone: +61 2 9978 3770
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: Basic Science, Randomized, Single Blind (Subject), Crossover Assignment, Bio-availability Study
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
AstraZeneca Clinical Study Information, Phone: +61 2 9978 3770
Research Site, Brisbane, Queensland, Australia; Recruiting
Additional Information
Starting date: September 2009
Ending date: October 2009
Last updated: October 8, 2009
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