PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
An Open-Label, 2-Period Pharmacokinetic Study to Evaluate the Intra-Subject Variability in Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400 Tablets
1 other identifier
interventional
18
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jan 2008
Shorter than P25 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 11, 2008
CompletedFirst Posted
Study publicly available on registry
January 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedApril 30, 2008
April 1, 2008
1 month
January 11, 2008
April 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic profile following dosing with PN400
24-hour PK on Day 1 & Day 10 of each treatment period
Secondary Outcomes (1)
To evaluate the safety of PN400
Day 1-10 of each treatment period
Interventions
500 mg esomeprazole/20 mg naproxen, once daily on Days 1-10 and twice daily on Days 2-9
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- POZENlead
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 11, 2008
First Posted
January 23, 2008
Study Start
January 1, 2008
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 30, 2008
Record last verified: 2008-04