PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
NCT00599404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2008-04-30
Summary
Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.
Conditions
- Healthy
Interventions
- DRUG
-
PN400
500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9
Sponsors & Collaborators
-
POZEN
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-01-31
- Primary Completion
- 2008-02-29
- Completion
- 2008-02-29
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