Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

PLx Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Naproxen

Drug: PL 3100

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00966641

PL-NAP-001

NIH Grant 1R44AR056529-01

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.