A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept®
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Corium, Inc.
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- PK, AUC
研究概览
简要总结
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®
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female
- •Body mass index ≥ 18.0 and ≤ 32.0 kg/m2 at screening
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator
- •Have a Fitzpatrick skin type of I, II or III or have skin colorimeter scores equivalent to the allowed Fitzpatrick skin type
排除标准
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (including piperidine derivatives and other cholinesterase inhibitors)
- •Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitable veins in both arms
- •Potential for occupational exposure to anticholinesterase agents.
- •Female subjects with a positive pregnancy test or lactating
- •Positive urine drug or alcohol results
- •Estimated creatinine clearance in non-elderly subjects <80 mL/min at screening and in elderly subjects (i.e., ≥55 years of age) <60 mL/min at screening
- •Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in
- •Any of the following drugs for 28 days prior to the first dose of study drug in Treatment Period 1 and throughout the study:
- •significant inducers of cytochrome P450 (CYP) enzymes and/or P-glycoprotein;
- •anti-inflammatory drugs or cyclooxygenase 2 (COX-2) analgesic;
- •beta-blockers;
- •anti-fungal medications;
- •anti-histamines;
- •cholinergics and anti-cholinergics;
- •oral corticosteroids;
- •adjuvant analgesics
- •Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
- •History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with drug absorption
- •History or presence of significant skin damage, diffuse skin diseases, scars, tattoos on the application sites or other skin disturbances as deemed by the Investigator to potentially interfere with drug absorption or irritation assessments
- •Use of donepezil hydrochloride or related drugs within 30 days prior to the first study drug administration
- •Participation in another clinical study within 30 days prior to the first study drug administration
- •Clinically significant depression symptoms or suicidal ideation or behavior as determined by the Investigator
研究组 & 干预措施
Donepezil TDS
Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks
干预措施: Donepezil TDS (Drug)
Aricept
Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks
干预措施: Aricept (Drug)
结局指标
主要结局
PK, AUC
时间窗: 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
时间窗: 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 \[HCl\]).
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Daily during 5 week treatment period and during the 5 week follow-on period)
- PI assessment of local skin irritation response to TDS(0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks))
- PI assessment of TDS Adhesion(Daily during 5 week treatment period)