Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 profiles of PL 3100 and naproxen at a prescription dose.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PLx Pharma
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.