Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PL 3100

Active experimental drug

Group Type EXPERIMENTAL

PL 3100

Intervention Type DRUG

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

Naproxen

Active comparator

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Single orally administered dose of 500 mg naproxen

Interventions

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Naproxen

Single orally administered dose of 500 mg naproxen

Intervention Type DRUG

PL 3100

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

Intervention Type DRUG

Other Intervention Names

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Naproxen-PC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes