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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Donepezil Hydrochloride Transdermal Delivery System
Aricept Tablet
Celerion Inc.
Phoenix, Arizona, United States
PK, AUC
To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride \[HCl\]).
Time frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
PK, Cmax
To assess the maximum observed concentrations (Cmax) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride \[HCl\]).
Time frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)
Time frame: Daily during 5 week treatment period and during the 5 week follow-on period
PI assessment of local skin irritation response to TDS
To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Dermal Response assessed using 8 point categorical scale. Other effects assessed using a 6 point scale.
Time frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks)
PI assessment of TDS Adhesion
Adhesion data will be collected during each 7-day patch wear period throughout 5 week treatment period. Percent adherence will be assessed using 12 point categorical scale.
Time frame: Daily during 5 week treatment period
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