Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

August 6, 2015 updated by: PLx Pharma

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77074
        • Houston Institute For Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PL 3100
Active experimental drug
Drug: PL 3100
Single orally administered dose of PL 3100 (500 mg naproxen)
Other Names:
  • Naproxen-PC
Active Comparator: Naproxen
Active comparator
Drug: Naproxen
Single orally administered dose of 500 mg naproxen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PLx Pharma

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Upendra K. Marathi, PhD, PLx Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL-NAP-001
  • NIH Grant 1R44AR056529-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on PL 3100

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe