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Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
PLx Pharma
ClinicalTrials.gov Identifier:
NCT00966641
First received: August 25, 2009
Last updated: May 10, 2010
Last verified: May 2010
History of Changes
  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:

U.S. FDA Resources

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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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 May 16, 2013