Clinical Trial: A Comparative Bioavailability and Adhesion Performance Study, Comparing a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Single-center, Crossover, Comparative Bioavailability and Adhesion Performance Study, Comparing Single Administrations of a New Scopolamine Transdermal Delivery System Formulation to the

Brief Summary: In this comparative bioavailability and in vivo skin adhesion study, the impact of minor changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and change of the manufacturing line of the micro porous membrane will be tested.

Detailed Summary: This study is a randomized, single-center, cross-over, comparative bioavailability and adhesion study, comparing single administrations of a new scopolamine transdermal delivery system formulation to the current established reference transdermal delivery system in healthy adult participants. The study will consist of an ambulant screening day within 21 days prior to the first investigational medicinal product (IMP) administration at study Day 1 and two treatment periods. Each treatment period will consist of 4.5 days (108 hours) of in-house confinement.
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Maximum plasma concentration (Cmax) [ Time Frame: upto 96 hours ]
    The maximum observed post-dose concentration.
  • Area under the curve from time zero extrapolated to infinity [AUC(0-inf)] [ Time Frame: upto 96 hours ]
    The area under the plasma concentration versus time curve will be calculated from time 0 to infinity.
  • Area under the curve from time zero to last sampling time [AUC(0-t)] [ Time Frame: upto 96 hours ]
    The area under the plasma concentration versus time curve will be calculated from time 0 to the last measurable sampling time point, t.
  • Time to reach maximum plasma concentration (Tmax) [ Time Frame: upto 96 hours ]
    The time of the maximum observed post-dose concentration.
  • Termination rate constant (Lambda_z) [ Time Frame: upto 96 hours ]
    The terminal elimination rate constant.
  • Percentage area under the curve by extrapolation (%AUCex) [ Time Frame: upto 96 hours ]
    Percentage of AUC0-inf obtained by extrapolation.
  • Elimination half life (t1/2) [ Time Frame: upto 96 hours ]
    The elimination half-life.
  • Patch adherence assessment [ Time Frame: upto Day 4 ]
    Patch adherence evaluation will be performed.
    • <

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Skin Irritation [ Time Frame: After 0.5 hour, 24 hours ]
      Skin irritation will be assessed at 0.5 hour and 24 hours after patch removal in each study period.
    • Safety Assessment [ Time Frame: upto Day 16 ]
      Safety assessments will consist of evaluation of skin for irritation, monitoring and recording of all adverse events including serious adverse events, physical examination, vital signs (including blood pressure, pulse rate and body temperature), laboratory tests.


    Original Secondary Outcome: Same as current

    Information By: GlaxoSmithKline

    Dates:
    Date Received: July 18, 2016
    Date Started: May 1, 2016
    Date Completion:
    Last Updated: April 10, 2017
    Last Verified: April 2017