Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

This study has been completed.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
PLx Pharma
ClinicalTrials.gov Identifier:
First received: August 25, 2009
Last updated: August 6, 2015
Last verified: August 2015

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:
  • 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. ] [ Designated as safety issue: No ]
    Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.

Enrollment: 34
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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00966641

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)
Principal Investigator: Upendra K. Marathi, PhD PLx Pharma Inc.
  More Information

No publications provided

Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT00966641     History of Changes
Other Study ID Numbers: PL-NAP-001, NIH Grant 1R44AR056529-01
Study First Received: August 25, 2009
Results First Received: June 22, 2015
Last Updated: August 6, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 09, 2015