A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|