NCT00966641

Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: PLx Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Naproxen	Single orally administered dose of 500 mg naproxen
DRUG	PL 3100	Single orally administered dose of PL 3100 (500 mg naproxen)

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-08-27
• Last updated: 2015-09-07
• Results posted: 2015-09-07

Locations

1 site across 1 country: United States