A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 500mg Alone, and Enteric-Coated Esomeprazole 20mg Alone.
1 other identifier
interventional
40
1 country
1
Brief Summary
A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2008
Shorter than P25 for phase_1
1 active site
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
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 5, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedDecember 23, 2008
December 1, 2008
2 months
September 5, 2008
December 19, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments
12-72 hour PK assessments
Secondary Outcomes (2)
To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments.
72-hour PK assessments
To evaluate the safety of each of the single-dose treatments
Entire study duration (48 days)
Study Arms (4)
1
EXPERIMENTALPN 400
2
ACTIVE COMPARATOREnteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)
3
ACTIVE COMPARATOREnteric-coated naproxen tablet (500mg)
4
ACTIVE COMPARATOREC esomeprazole capsule (20mg)
Interventions
A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
Eligibility Criteria
You may qualify if:
- Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- POZENlead
Study Sites (1)
PPD
Austin, Texas, 78744, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 5, 2008
First Posted
September 9, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
December 23, 2008
Record last verified: 2008-12