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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PN400; Drug: Naprosyn

• Registration Number: NCT00992381
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study Completion: 2009-10
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	PN400	PN400
2	Naprosyn	Naproxen

Primary Outcome Measures

Name	Time	Method
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	blood samples taken at various time points over 2 treatment periods of 11 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet,	Blood samples taken at various time point over 2 periods of 2 days
Compare the adverse event profile of PN 400 with that from Naprosyn®	Adverse event reporting over 2 periods of 11 days

Trial Locations

Locations (1)

Research Site; 🇦🇺 Brisbane, Queensland, Australia