Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
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)
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Sep 2009
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 8, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedJanuary 18, 2010
January 1, 2010
October 8, 2009
January 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
1
EXPERIMENTALPN400
2
ACTIVE COMPARATORNaproxen
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- POZENcollaborator
Study Sites (1)
Research Site
Brisbane, Queensland, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Terry Hurst
Q-Pharm Phase one unit
- PRINCIPAL INVESTIGATOR
Jo Marjason
Q-Pharm Phase one unit
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 8, 2009
First Posted
October 9, 2009
Study Start
September 1, 2009
Study Completion
October 1, 2009
Last Updated
January 18, 2010
Record last verified: 2010-01