Back to resultsStudy Evaluating the Effect of Food on the Bioavailability of PN400 Components
Primary Purpose
Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PN400
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 old 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 4
Arm Type
Other
Other
Other
Other
Arm Label
1
2
3
4
Arm Description
PN400 administered after meal
PN400 administered prior to meal
PN400 administered prior to meal
PN400 followed by fast
Outcomes
Primary Outcome Measures
To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects.
Secondary Outcome Measures
To assess the safety and tolerability of PN 400 under fasting and fed conditions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00676442
Brief Title
Study Evaluating the Effect of Food on the Bioavailability of PN400 Components
Official Title
An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 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 effect of food on the bioavailability of the components of PN400
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
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
PN400 administered after meal
Arm Title
2
Arm Type
Other
Arm Description
PN400 administered prior to meal
Arm Title
3
Arm Type
Other
Arm Description
PN400 administered prior to meal
Arm Title
4
Arm Type
Other
Arm Description
PN400 followed by fast
Intervention Type
Drug
Intervention Name(s)
PN400
Intervention Description
naproxen/esomeprazole
Primary Outcome Measure Information:
Title
To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects.
Time Frame
72-hours
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of PN 400 under fasting and fed conditions.
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 old 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 Effect of Food on the Bioavailability of PN400 Components
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