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