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Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966641
First Posted: August 27, 2009
Last Update Posted: September 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
PLx Pharma
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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. ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT00966641     History of Changes
Other Study ID Numbers: PL-NAP-001
NIH Grant 1R44AR056529-01
First Submitted: August 25, 2009
First Posted: August 27, 2009
Results First Submitted: June 22, 2015
Results First Posted: September 7, 2015
Last Update Posted: September 7, 2015
Last Verified: August 2015

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
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action