Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers
1 other identifier
interventional
30
1 country
1
Brief Summary
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 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
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJune 10, 2008
June 1, 2008
3 months
April 23, 2008
June 9, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
72-hour PK
Secondary Outcomes (1)
To evaluate the safety of the 3 treatments
entire study duration
Study Arms (3)
A
EXPERIMENTALPN400 (naproxen/esomeprazole)
B
ACTIVE COMPARATORnaproxen 500 mg
C
ACTIVE COMPARATORnaproxen 500 mg
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- POZENlead
Study Sites (1)
Unknown Facility
Austin, Texas, 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
April 23, 2008
First Posted
April 24, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
June 10, 2008
Record last verified: 2008-06