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Bioequivalence Minocycline Bioequivalence

Primary Purpose

Skin Infections (Acne)

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Minocycline 100mg
Minocycline 100mg
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Infections (Acne) focused on measuring Minocycline, Mexico, Acne, bioequivalence

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Males 18-55 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    A(reference)/B(test)

    B(test)/A(reference)

    Arm Description

    initial administration of reference and cross-over to test

    initial administration of test and cross-over to reference

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2012
    Last Updated
    June 21, 2017
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01755611
    Brief Title
    Bioequivalence Minocycline Bioequivalence
    Official Title
    Bioequivalence Study Between Two Medications for Oral Administration of Minocycline in 100 mg Oral Solids in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 17, 2011 (Actual)
    Primary Completion Date
    June 25, 2011 (Actual)
    Study Completion Date
    June 25, 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 aim of the study is to compare the bioavailability of two medications containing 100 mg of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin® is a registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is randomized, open, cross-over with two single administrations with two periods and two sequences with a wash-out period of 7 days between the periods. Subjects in the study will be 25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours after medication administration in each period. Plasma minocycline levels will be determined by HPLC method with UV detection with previously validated method. Minocycline concentration data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3 software. The log transformed pharmacokinetics parameters of test and reference medications will be compared calculating ratios and 90% confidence intervals. Any adverse event will be reported.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Infections (Acne)
    Keywords
    Minocycline, Mexico, Acne, bioequivalence

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    A(reference)/B(test)
    Arm Type
    Experimental
    Arm Description
    initial administration of reference and cross-over to test
    Arm Title
    B(test)/A(reference)
    Arm Type
    Experimental
    Arm Description
    initial administration of test and cross-over to reference
    Intervention Type
    Drug
    Intervention Name(s)
    Minocycline 100mg
    Other Intervention Name(s)
    MINOPAC® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.
    Intervention Description
    Test product
    Intervention Type
    Drug
    Intervention Name(s)
    Minocycline 100mg
    Other Intervention Name(s)
    MINOCIN® is a registered trademark of Wyeth Holdings Corporation
    Intervention Description
    Reference product
    Primary Outcome Measure Information:
    Title
    Peak Plasma Concentration (CMAX) of drug minocycline
    Description
    Pharmacokinetics
    Time Frame
    0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours postdose
    Title
    Area under the plasma concentration versus time curve (AUC) of drug minocycline
    Description
    Pharmacokinetics
    Time Frame
    0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours postdose

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Males 18-55 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

    Learn more about this trial

    Bioequivalence Minocycline Bioequivalence

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