Back to resultsStudy Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
Primary Purpose
Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PN400
naproxen
naproxen
Sponsored by
About this trial
This is an interventional basic science trial for Arthritis
Eligibility Criteria
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 exclusion criteria for a study of this nature
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
A
B
C
Arm Description
PN400 (naproxen/esomeprazole)
naproxen 500 mg
naproxen 500 mg
Outcomes
Primary Outcome Measures
To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
Secondary Outcome Measures
To evaluate the safety of the 3 treatments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00665743
Brief Title
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
POZEN
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
PN400 (naproxen/esomeprazole)
Arm Title
B
Arm Type
Active Comparator
Arm Description
naproxen 500 mg
Arm Title
C
Arm Type
Active Comparator
Arm Description
naproxen 500 mg
Intervention Type
Drug
Intervention Name(s)
PN400
Intervention Description
naproxen 500 mg /esomeprazole 20 mg
Intervention Type
Drug
Intervention Name(s)
naproxen
Intervention Description
naproxen 500 mg tablet
Intervention Type
Drug
Intervention Name(s)
naproxen
Intervention Description
naproxen 500 mg
Primary Outcome Measure Information:
Title
To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
Time Frame
72-hour PK
Secondary Outcome Measure Information:
Title
To evaluate the safety of the 3 treatments
Time Frame
entire study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 exclusion criteria for a study of this nature
Facility Information:
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
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