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Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Sponsor
PLx Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT00966641
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
34
Enrollment
1
Location
2
Arms
2
Duration (Months)
17
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
"A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: PL 3100

Active experimental drug

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

    		•
    Active Comparator: Naproxen

    Active comparator

    Drug: Naproxen
    Single orally administered dose of 500 mg naproxen

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Houston Institute for Clinical Research Houston Texas United States 77074

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Upendra K. Marathi, PhD, PLx Pharma Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PLx Pharma
    ClinicalTrials.gov Identifier:
    NCT00966641
    Other Study ID Numbers:
    • PL-NAP-001
    • NIH Grant 1R44AR056529-01
    First Posted:
    Aug 27, 2009
    Last Update Posted:
    Sep 7, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Naproxen

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title PL3100 First, Then Naproxen Naproxen First, Then PL3100
    Arm/Group Description First Intervention Period: PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen) (after 7-14 day washout period) Second Intervention Period: Naproxen: Single orally administered dose of 500 mg naproxen First Intervention Period: Naproxen: Single orally administered dose of 500 mg naproxen (after 7-14 day washout period) Second Intervention Period: PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)
    Period Title: First Intervention
    STARTED 17 17
    COMPLETED 17 17
    NOT COMPLETED 0 0
    Period Title: First Intervention
    STARTED 17 17
    COMPLETED 17 17
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title All Study Participants
    Arm/Group Description All study participants who were enrolled in the study.
    Overall Participants 34
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    38.2
    (12.43)
    Sex: Female, Male (Count of Participants)
    Female
    20
    58.8%
    Male
    14
    41.2%

    Outcome Measures

    1. Primary Outcome
    Title Area Under the Curve of Plasma Naproxen From 0 to t
    Description Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.
    Time Frame 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.

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) Evaluable Population consists of the 28 subjects who completed the study with no protocol deviations.
    Arm/Group Title PL 3100 Naproxen
    Arm/Group Description Active experimental drug PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen) Active comparator Naproxen: Single orally administered dose of 500 mg naproxen
    Measure Participants 28 28
    Mean (Full Range) [min×μg/mL]
    67763.0
    69427.9

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title PL 3100 Naproxen
    Arm/Group Description Active experimental drug PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen) Active comparator Naproxen: Single orally administered dose of 500 mg naproxen
    All Cause Mortality
    PL 3100 Naproxen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    PL 3100 Naproxen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/34 (0%) 0/34 (0%)
    Other (Not Including Serious) Adverse Events
    PL 3100 Naproxen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/34 (2.9%) 0/34 (0%)
    Blood and lymphatic system disorders
    Elevated Partial Thromboplastin Time 1/34 (2.9%) 1 0/34 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Standard Confidentiality Agreement

    Results Point of Contact

    Name/Title Ronald Zimmerman
    Organization PLx Pharma
    Phone 1-713-842-1249 ext 205
    Email ron.zimmerman@plxpharma.com
    Responsible Party:
    PLx Pharma
    ClinicalTrials.gov Identifier:
    NCT00966641
    Other Study ID Numbers:
    • PL-NAP-001
    • NIH Grant 1R44AR056529-01
    First Posted:
    Aug 27, 2009
    Last Update Posted:
    Sep 7, 2015
    Last Verified:
    Aug 1, 2015