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Bioequivalence Study for Terbinafine 250 mg

Primary Purpose

Mycoses

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Terbinafine 250 mg
Terbinafine 250 mg
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mycoses focused on measuring Mexico, terbinafine, mycoses, pharmacokinetics

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion Criteria: Males 18-50 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent. -

Exclusion Criteria:

Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.

Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation =>450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study.

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    A(test)/B(reference)

    B(reference)/A(test)

    Arm Description

    Initial administration of test and crossover to reference

    Initial administration of reference and crossover to test

    Outcomes

    Primary Outcome Measures

    Peak Plasma Concentration (CMAX) of drug terbinafine
    pharmacokinetics
    Area under the plasma concentration versus time curve (AUC) of drug terbinafine
    pharmacokinetics

    Secondary Outcome Measures

    Full Information

    First Posted
    January 17, 2013
    Last Updated
    June 21, 2017
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01772212
    Brief Title
    Bioequivalence Study for Terbinafine 250 mg
    Official Title
    Bioequivalence Study Between Two Medications for the Oral Administration of Terbinafine 250 mg in Oral Solids in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 24, 2011 (Actual)
    Primary Completion Date
    March 15, 2011 (Actual)
    Study Completion Date
    March 15, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study was to confirm if two formulations of terbinafine (tablets) are bioequivalent. Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product Lamisil® 250 mg (Novartis). One tablet was the single dosage. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 30 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mycoses
    Keywords
    Mexico, terbinafine, mycoses, pharmacokinetics

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A(test)/B(reference)
    Arm Type
    Experimental
    Arm Description
    Initial administration of test and crossover to reference
    Arm Title
    B(reference)/A(test)
    Arm Type
    Experimental
    Arm Description
    Initial administration of reference and crossover to test
    Intervention Type
    Drug
    Intervention Name(s)
    Terbinafine 250 mg
    Other Intervention Name(s)
    Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier
    Intervention Description
    Test product
    Intervention Type
    Drug
    Intervention Name(s)
    Terbinafine 250 mg
    Other Intervention Name(s)
    Lamisil® is a registered trademark of Novartis
    Intervention Description
    Reference product
    Primary Outcome Measure Information:
    Title
    Peak Plasma Concentration (CMAX) of drug terbinafine
    Description
    pharmacokinetics
    Time Frame
    0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post dose
    Title
    Area under the plasma concentration versus time curve (AUC) of drug terbinafine
    Description
    pharmacokinetics
    Time Frame
    0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Inclusion Criteria: Males 18-50 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent. - Exclusion Criteria: Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition. Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation =>450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Bioequivalence Study for Terbinafine 250 mg

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