Phase 1, open-label, randomized, 3-period, 3-treatment, crossover pharmacokinetic study to evaluate the steady-state pharmacokinetics of 5 mg/day and 10 mg/day Corplex™ Donepezil TDS manufactured with the commercial process compared to 10 mg Aricept® in healthy volunteers.
Screening Period: Subjects will undergo a Screening Period up to 28 days prior to entering the Treatment Phase. Treatment Phase consisting of 3 Treatment periods with 3 Treatments A, B, C. Treatment Period 1: All Subjects will receive Treatment A; 5 mg/day Donepezil Transdermal Delivery System (TDS); 1-week wear and applied for 5 consecutive weeks. Treatment Periods 2 and 3: Subjects will be randomized (by gender) to receive either sequences of Treatments B-C or Treatments C-B. Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks Treatment C: 10 mg/day Aricept® donepezil tablet administered daily (QD) for 5 weeks. Blood samples for pharmacokinetics and safety assessments will be collected during the Treatment Phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Transdermal Delivery System
Oral
Worldwide Clinical Trials
San Antonio, Texas, United States
Maximum Concentration (Cmax)
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
Time frame: 35 days of each Treatment
Area Under the Curve (AUC)
To evaluate steady-state donepezil plasma exposure (AUC) following 5 weeks of treatment
Time frame: 35 days each Treatment
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