Pharmacokinetics Clinical Trial
Official title:
An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron
This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.
Sancuso® (granisetron transdermal system [TDS] or patch) was approved by the United States
(US) Food and Drug Administration (FDA) in September 2008, indicated for the prevention of
nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy
regimens of up to 5 consecutive days' duration.
While in vivo pharmacokinetic studies with Sancuso® in healthy adults and in subjects
receiving chemotherapy have been conducted, there are limited data from subjects who have
altered skin integrity due to advanced age or poor nutritional status related to chronic
illness. In addition, available data suggest that granisetron is delivered into subcutaneous
fat and is released from that compartment over time. It is possible that individuals with
varying nutritional status and resultant differences in subcutaneous fat would have
differences in pharmacokinetics.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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