Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
PLx Pharma
ClinicalTrials.gov Identifier:
NCT00966641
First received: August 25, 2009
Last updated: May 10, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Naproxen
Drug: PL 3100
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"

Resource links provided by NLM:


Further study details as provided by PLx Pharma:

Primary Outcome Measures:
  • Pharmacokinetic measures of plasma naproxen [ Time Frame: Single dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic bioequivalence of PL 3100 and comparator naproxen [ Time Frame: Single dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PL 3100
Active experimental drug
Drug: PL 3100
Single orally administered dose of PL 3100 (500 mg naproxen)
Other Name: Naproxen-PC
Active Comparator: Naproxen
Active comparator
Drug: Naproxen
Single orally administered dose of 500 mg naproxen

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966641

Locations
United States, Texas
Houston Institute for Clinical Research
Houston, Texas, United States, 77074
Sponsors and Collaborators
PLx Pharma
Investigators
Principal Investigator: Upendra K. Marathi, PhD PLx Pharma Inc.
  More Information

No publications provided

Responsible Party: Dr. Upendra Marathi, Senior Vice President, PLx Pharma Inc.
ClinicalTrials.gov Identifier: NCT00966641     History of Changes
Other Study ID Numbers: PL-NAP-001, NIH Grant 1R44AR056529-01
Study First Received: August 25, 2009
Last Updated: May 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014