CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Naproxen +1 moredrug
Likely dose
Naproxen 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00966641
NCT00966641Phase 2Completed
CompareCT.gov

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

PLx Pharma·interventional·Posted Aug 27, 2009·Updated Sep 7, 2015

In Brief

A Phase 2 clinical trial evaluating Naproxen and PL 3100 for Healthy Volunteers. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 27, 2009
Enrollment StartAug 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.8 years ago

Interventions

Naproxendrug

Single orally administered dose of 500 mg naproxen

PL 3100drug

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