Back to resultsA Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
Primary Purpose
Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PN 400
EC naproxen plus EC esomeprazole
EC naproxen
EC esomeprazole
Sponsored by
About this trial
This is an interventional basic science trial for Arthritis
Eligibility Criteria
Inclusion Criteria:
- Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.
Exclusion Criteria:
- Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.
Sites / Locations
- PPD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
PN 400
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)
Enteric-coated naproxen tablet (500mg)
EC esomeprazole capsule (20mg)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
To evaluate the safety of each of the single-dose treatments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00749385
Brief Title
A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
POZEN
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.
Detailed Description
This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.
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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PN 400
Arm Title
2
Arm Type
Active Comparator
Arm Description
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Enteric-coated naproxen tablet (500mg)
Arm Title
4
Arm Type
Active Comparator
Arm Description
EC esomeprazole capsule (20mg)
Intervention Type
Drug
Intervention Name(s)
PN 400
Intervention Description
A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
Intervention Type
Drug
Intervention Name(s)
EC naproxen plus EC esomeprazole
Other Intervention Name(s)
EC Naprosyn and Nexium
Intervention Description
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
Intervention Type
Drug
Intervention Name(s)
EC naproxen
Other Intervention Name(s)
EC Naprosyn
Intervention Description
Enteric-coated naproxen tablet (500mg)
Intervention Type
Drug
Intervention Name(s)
EC esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
Enteric-coated esomeprazole capsule (20mg)
Primary Outcome Measure Information:
Title
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
Time Frame
12-72 hour PK assessments
Secondary Outcome Measure Information:
Title
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.
Time Frame
72-hour PK assessments
Title
To evaluate the safety of each of the single-dose treatments
Time Frame
Entire study duration (48 days)
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 males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.
Exclusion Criteria:
Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.
Facility Information:
Facility Name
PPD
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
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