"A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"

PLx Pharma1 site in 1 country34 target enrollmentAugust 2009

ConditionsHealthy Volunteers

InterventionsNaproxen PL 3100

DrugsNaproxen PL 3100

Overview

Phase: Phase 1
Intervention: Naproxen
Conditions: Healthy Volunteers
Sponsor: PLx Pharma
Enrollment: 34
Locations: 1
Primary Endpoint: Area Under the Curve of Plasma Naproxen From 0 to t
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 profiles of PL 3100 and naproxen at a prescription dose.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

October 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

PLx Pharma

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Naproxen

Active comparator

Intervention: Naproxen

PL 3100

Active experimental drug

Intervention: PL 3100

Outcomes

Primary Outcomes

Area Under the Curve of Plasma Naproxen From 0 to t

Time Frame: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.

Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.