Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
1 other identifier
interventional
30
1 country
1
Brief Summary
We will evaluate the bioavailability of naproxen 375 mg in two 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 Jun 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedSeptember 5, 2008
September 1, 2008
1 month
June 4, 2008
September 4, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations
72-hour PK
Secondary Outcomes (1)
To evaluate the safety of the two treatments
entire study duration
Study Arms (2)
1
EXPERIMENTALPN400
2
ACTIVE COMPARATORnaproxen 375 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
June 4, 2008
First Posted
June 6, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
September 5, 2008
Record last verified: 2008-09