Pain Clinical Trial
Official title:
A Two-period, Randomised, Open-label, Crossover, Pharmacokinetic Study to Assess the Bioequivalence and Adhesion of Buprenorphine Transdermal System Second Generation Patch Compared With First Generation Patch, in Healthy Volunteers
To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of drug) and that they equally both stick to the skin over 7 days of continuous wear.
The objective is to compare a 2nd generation BTDS patch 20 µg/h to the 1st generation patch
to confirm bioequivalence. Determination will be via measurement of drug concentrations in
the blood at serial collection time points pre-dose until 288 hours post-patch application.
Approximately 100 healthy male and female volunteers will receive both BTDS patches across
two study periods with a 14-day wash-out between applications.
Each patch will be worn for 7 consecutive days and the study will also review the adhesion
of each patch to the skin of the subjects. The overall safety and tolerability of both
patches will be assessed.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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