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Completed

NCT Number: NCT00966641

Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Houston Institute for Clinical Research

Houston, Texas, 77074, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxen

Drug

Single orally administered dose of 500 mg naproxen

PL 3100

Drug

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

Other names: Naproxen-PC

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

PLx Pharma

Industry

Collaborators

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

Registry information

Official study title

"A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2009
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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