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  • Dapsone DPK Study Synopsis

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    This document provides a protocol synopsis for a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, two-way crossover dermatological pharmacokinetic study of doxycycline 40% gel in 48 healthy adult subjects. The study will evaluate the bioequivalence of a test formulation of doxycycline 40% gel manufactured by Company XXX compared to the reference listed drug Aczone gel. Over two periods, subjects will receive a single application of either the test or reference gel to their skin in a crossover design. Skin stripping samples will be taken from the application sites at various time points to measure doxycycline levels and evaluate the pharmacokinetic profile.

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    Dermatopharmackinetic study for Dapsone Gel

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    This document provides a protocol synopsis for a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, two-way crossover dermatological pharmacokinetic study of doxycycline 40% gel in 48 healthy adult subjects. The study will evaluate the bioequivalence of a test formulation of doxycycline 40% gel manufactured by Company XXX compared to the reference listed drug Aczone gel. Over two periods, subjects will receive a single application of either the test or reference gel to their skin in a crossover design. Skin stripping samples will be taken from the application sites at various time points to measure doxycycline levels and evaluate the pharmacokinetic profile.

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    © All Rights Reserved
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    16 views2 pages

    Dapsone DPK Study Synopsis

    Uploaded by

    jk6099
    This document provides a protocol synopsis for a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, two-way crossover dermatological pharmacokinetic study of doxycycline 40% gel in 48 healthy adult subjects. The study will evaluate the bioequivalence of a test formulation of doxycycline 40% gel manufactured by Company XXX compared to the reference listed drug Aczone gel. Over two periods, subjects will receive a single application of either the test or reference gel to their skin in a crossover design. Skin stripping samples will be taken from the application sites at various time points to measure doxycycline levels and evaluate the pharmacokinetic profile.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
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    Protocol Synopsis

    Name of the Sponsor with Address XXX


    Protocol Title
    A Randomized, open label, two-treatment, two-period, two-sequence, single
    dose, two-way crossoer, !ermatological Pharmaco"inetic study of
    !apsone #$ gel of %%%% in &' healthy human adult sub(ects)
    Test Product Name with strength !apsone #$ gel
    *ormulation
    Topical Application
    Pilot+Piotal
    Pilot
    ,ountry of Submission
    -S*!A
    Investigational Products Details
    Test formulation
    !rug Name
    !apsone #$ gel
    .anufactured by
    %%%
    Reference formulation
    !rug Name
    Aczone/
    0rand Name 1if any2
    !apsone #$ gel
    .anufactured by
    Allergan, 3nc), -SA
    Sample Size 4 5ustification 13f
    aailable26
    The required sample size was calculated assuming &' sub(ects would be
    sufficient to analyse the bio-equialence of test and R7!)
    Study Design
    Period6 Two+Three+*our
    Two
    ,ross oer+Parallel+8ther
    ,ross oer
    No) of 9olunteers &'
    Type of Study6 *asting+*ed NA
    S"in stripping Time Points Control (area without drug application), after 15, !, "! and 1#!
    $inutes% &dditional stripping fro$ ' sites at 1#! $inutes%
    Number of -nits to dose6 Single application
    Sample ,ollection tubes6 1:;+ :<
    =!TA+any other26
    To be confirmed
    Sample 6 Adhesie tape stripped from application sites
    9olume of Sample for each time point6 To be confirmed
    No) of s"in stripping samples + site6 Ten
    Analyte1s2 to measure6 !apsone
    Re(uenation of stratum corneum6 ;> days
    Specific ,onditions 1if any26
    (eference)
    http6++www)allergan)com+assets+pdf+aczone?pi)pdf
    http6++www)fda)go+ohrms+doc"ets+ac+&&+bac"grd+<''@b@c)pdf
    http6++www)accessdata)fda)go+drugsatfda?docs+nda+;&&#+&;@ABCs&&&?,linPharmR)pdf

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