PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00599404
- Lead Sponsor
- POZEN
- Brief Summary
Pharmacokinetic study in healthy subjects with single and repeat b.i.d. dosing of PN 400 tablets from the same drug product batch.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature
Exclusion Criteria
Standard inclusion criteria for a study of this nature
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile following dosing with PN400 24-hour PK on Day 1 & Day 10 of each treatment period
- Secondary Outcome Measures
Name Time Method To evaluate the safety of PN400 Day 1-10 of each treatment period