Status:
COMPLETED
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
Lead Sponsor:
PLx Pharma
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic pr...
Eligibility Criteria
Inclusion
- Age 18-75 years, inclusive.
- Subject has a Body Mass Index (BMI) between 20 and 32, inclusive.
- Normal physical examination as determined by the Investigator.
- Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit.
- If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing.
- If female and of child-bearing potential, the subject must agree to use adequate birth control for the duration of the study.
Exclusion
- Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol.
- Subject has had an acute illness within 5 days of study medication administration.
- Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
- Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00966641
Start Date
August 1 2009
End Date
October 1 2009
Last Update
September 7 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Houston Institute for Clinical Research
Houston, Texas, United States, 77074