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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
134
Part 1 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.
Part 2 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.
PPD Development
Austin, Texas, United States
Area under the plasma concentration versus time curve AUC (0-t)
AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule
Time frame: 6 months
Area under the plasma concentration versus time curve AUC (0-inf)
AUC from time 0 extrapolated to infinity, calculated as (AUC 0-t + \[Clast/λz\]) where Clast is the last measurable plasma concentration
Time frame: 6 months
Peak Plasma Concentration (Cmax)
Maximum concentration after dosing
Time frame: 6 months
Maximum concentration (Tmax)
Time to reach the maximum plasma concentration after dosing (Tmax)
Time frame: 6 months
T1/2
Terminal phase half-life
Time frame: 6 months
CL/F
Total clearance after dosing
Time frame: 6 months
Vz/F
Apparent volume of distribution during the terminal phase, calculated as (CL/F)λz
Time frame: 6 months
Mean adhesion score (FDA scale)
Adhesion of the patch to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion is: 0 = ≥ 90% adhered (essentially no lift off the skin), 1 = ≥ 75% to \< 90% adhered (some edges only lifting off the skin), 2 = ≥ 50% to \< 75% adhered (less than half of the patch lifting off the skin), 3 = \> 0% to \< 50% adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely off the skin). Adhesion is assessed daily when patches are insitu. The mean adhesion score will be derived from its individual adhesion scores at each assessment time point, averaged across all the equally spaced time points (except baseline timepoint). Difference in mean adhesion score between test and reference transdermal patches will be compared using a mixed-model analysis of variance.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months
Number of subjects with treatment related adverse events will be as assessed as mild, moderate or severe and will be summarized descriptively and presented as frequency and percentage.
Actual values and changes from baseline for clinical laboratory test results, vital sign measurements and 12-lead ECG results will be summarized by test and reference patches at each time point using descriptive statistics (number of subjects, mean, SD, median, minimum and maximum)
Time frame: 6 Months
Adhesion performance score (FDA Scale)
Adhesion of the patch to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion is: 0 = ≥ 90% adhered (essentially no lift off the skin), 1 = ≥ 75% to \< 90% adhered (some edges only lifting off the skin), 2 = ≥ 50% to \< 75% adhered (less than half of the patch lifting off the skin), 3 = \> 0% to \< 50% adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely off the skin). Adhesion is assessed daily when patches are insitu. Proportion of subjects with adhesion performance score of interest will be compared between the test and reference transdermal patches. Time to mean adhesion score more than or equal to 2 will be investigated graphically if data warrant.
Time frame: 6 Months