Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Naproxen; Drug: PL 3100

• Registration Number: NCT00966641
• Lead Sponsor: PLx Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-27
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2015-06-22
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-06
• Last Update Submitted: 2015-08-06
• Results First Posted: 2015-09-07
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Naproxen	Naproxen	Active comparator
PL 3100	PL 3100	Active experimental drug

Primary Outcome Measures

Name	Time	Method
Area Under the Curve of Plasma Naproxen From 0 to t	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.

Trial Locations

Locations (1)

Houston Institute for Clinical Research; 🇺🇸 Houston, Texas, United States