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Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

NCT00966641 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-09-07

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Naproxen

Single orally administered dose of 500 mg naproxen

DRUG

PL 3100

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

Sponsors & Collaborators

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

    collaborator NIH

  • PLx Pharma

    lead INDUSTRY

Principal Investigators

  • Upendra K. Marathi, PhD · PLx Pharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00966641 on ClinicalTrials.gov