Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Completed · Phase 1/Phase 2

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT00966641

Run by

PLx Pharma

People needed

34

Starts

2009-08-01

Expected to finish

2009-10-01

Last updated by the study team

2015-09-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Houston Institute for Clinical Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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