Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966641
• Other study ID #: PL-NAP-001
• Secondary ID: NIH Grant 1R44AR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 25, 2009
• Last updated: August 6, 2015
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2015
• Source: PLx Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Naproxen
Single orally administered dose of 500 mg naproxen
• PL 3100
Single orally administered dose of PL 3100 (500 mg naproxen)

Locations

Country	Name	City	State
United States	Houston Institute for Clinical Research	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
PLx Pharma	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No