Alzheimer's Disease Clinical Trial
Official title:
A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept®
A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg Transdermal Delivery System (TDS) compared to daily administration of Aricept®
Open label, randomized, 2-period, multiple-dose crossover study.
Approximately 86 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first study product
treatment in treatment period 1.
For each treatment period; subjects will receive donepezil for 5 consecutive weeks. Blood
samples for donepezil PK will be collected pre-dose through week 10.
Adhesion and skin irritation will be monitored throughout TDS treatments. Safety will be
monitored throughout the study by adverse event reporting, repeated clinical and laboratory
evaluations.
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