Status:
COMPLETED
Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
POZEN
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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®), w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00992381
Start Date
September 1 2009
End Date
October 1 2009
Last Update
January 18 2010
Active Locations (1)
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1
Research Site
Brisbane, Queensland, Australia