Status:
COMPLETED
A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
Lead Sponsor:
POZEN
Conditions:
Arthritis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.
Detailed Description
This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), e...
Eligibility Criteria
Inclusion
- Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.
Exclusion
- Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00749385
Start Date
August 1 2008
End Date
October 1 2008
Last Update
December 23 2008
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78744