The purpose of this study is to determine the effect of heat applied to a granisetron transdermal patch in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
IV
patch
Quotient Clinical Limited
Edinburgh, United Kingdom
Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied
To assess the effect of locally applied heat on the pharmacokinetic profile of granisetron delivered from the patch. Subjects will be randomized to receive Treatment A Sancuso patch ONLY and Treatment B, Sancuso PLUS Cura-Heat pad. Sancuso will be worn by the subjects for 5 days continuously. The Cura-Heat pad will be applied over the patch for 4.5 hours on each of the 5 days. During these 5 days PK sampling is planned to measure the initial release of granisetron from the patch and cover the predicted maximum observed concentrations with or without the Cura-Heat pad in place.
Time frame: 0 - 196 hours post dose
Safety and tolerability assessment
Safety and tolerability will be assessed by collection of adverse events, safety laboratory assessments, record of vital signs, conduct of physical examination and 12 lead ECG. In addition skin reaction at the patch and Cura-Heat pad application sites will be monitored.
Time frame: Up to 23 days post dose
residual granisetron after patch use in healthy subjects
• Residual granisetron after patch use and the calculation of in-vitro flux will be measured. All used patches will be returned to the manufacturer who will measure the amount of remaining granisetron in the patch and then the in-vitro flux will be calculated as follows: Amount delivered(assay amount-residual)/ number of days the patch was applied to the skin
Time frame: 120 hours post dose
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