Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.
brief summary
The study is designed to evaluate the BE and adhesion properties of granisetron transdermal patches manufactured at 2 different sites. The study has been designed in accordance with the FDA Guidance for Industry. Bioequivalence will be based on the Cmax and AUC to determine the peak and total drug exposure, respectively.
detailed description
This is a single-center, randomized, 2-part, open-label, crossover study in healthy subjects to establish bioequivalence (Part 1) and evaluate adhesion (Part 2) between granisetron transdermal patches manufactured at 2 different sites (Sancuso \[test\] and Sancuso \[reference\]).
Each part of the study will consist of a screening period, check-in days, treatment periods, washout period (Part 1 only), and an end-of-study visit. The duration of subject participation, excluding screening, for Part 1 is approximately 39 days and for Part 2 is approximately 17 days.
official title
A Randomized, Open-Label, Replicate Treatment, 2-Part, Crossover Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches Manufactured at Different Sites.