Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

NCT00966641 | Completed Phase 1 Results DMC

• 2 other identifiers: PL-NAP-001NIH Grant 1R44AR056529-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve of Plasma Naproxen From 0 to t

  Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.

  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.

Study Arms (2)

PL 3100

EXPERIMENTAL

Active experimental drug

Drug: PL 3100

Naproxen

ACTIVE COMPARATOR

Active comparator

Drug: Naproxen

Interventions

Naproxen DRUG

Single orally administered dose of 500 mg naproxen

Naproxen

PL 3100 DRUG

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

Also known as: Naproxen-PC

PL 3100

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• PLx Pharma: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Houston Institute for Clinical Research

Houston, Texas, 77074, United States

Location

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Ronald Zimmerman
• Organization: PLx Pharma

ron.zimmerman@plxpharma.com

1-713-842-1249

Study Officials

• Upendra K. Marathi, PhD

  PLx Pharma Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2009
• First Posted: August 27, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 7, 2015
• Results First Posted: September 7, 2015

Record last verified: 2015-08

Locations

US (1)