A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®
|ClinicalTrials.gov Identifier: NCT03259958|
Recruitment Status : Completed
First Posted : August 24, 2017
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Donepezil TDS Drug: Aricept||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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®|
|Actual Study Start Date :||October 30, 2017|
|Actual Primary Completion Date :||March 13, 2018|
|Actual Study Completion Date :||March 14, 2018|
Experimental: Donepezil TDS
Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System
Active Comparator: Aricept
Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks
- PK, AUC [ Time Frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total ]To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
- PK, Cmax [ Time Frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total ]To assess the maximum observed concentrations (Cmax) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Daily during 5 week treatment period and during the 5 week follow-on period ]General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)
- PI assessment of local skin irritation response to TDS [ Time Frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks) ]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.
- PI assessment of TDS Adhesion [ Time Frame: Daily during 5 week treatment period ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259958
|United States, Arizona|
|Phoenix, Arizona, United States, 85283|
|Principal Investigator:||Danielle Armas, MD||Celerion|