Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

PLx Pharma34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

NaproxenDRUG

Single orally administered dose of 500 mg naproxen

PL 3100DRUG

Single orally administered dose of PL 3100 (500 mg naproxen)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Houston Institute for Clinical Research

Houston, Texas, United States

Outcomes

Primary Outcomes

Area Under the Curve of Plasma Naproxen From 0 to t

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

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.

Data from ClinicalTrials.gov

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