A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Corium, Inc.
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Pharmacokinetics, CMAX
研究概览
简要总结
A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
详细描述
Randomized, open-label, 3-way crossover study
Up to 66 healthy, adult male and female subjects will be enrolled.
All subjects will receive Corplex Donepezil TDS patches applied to 3 different locations on each subject (back, buttock, and leg) during 3 different, consecutive treatment periods. For each subject, the location of product administration during each treatment period will be randomized.
During each treatment period, all subjects will receive a once-weekly 10 mg TDS, target dose 10 mg donepezil/day, applied for 7 days (1 week) on either the back, buttock, or leg in accordance with the randomized treatment location for that treatment period.
Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period. The PK sample collection time points are as follows:
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
- •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
- •Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
- •History or presence of significant skin damage or other skin disturbances as deemed by the Investigator to potentially interfere with patch procedures
- •Use of donepezil hydrochloride or related drugs within 60 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 Back
Corplex Donepezil TDS 10 mg/day applied to the Back for 1 week (7 days)
干预措施: Donepezil TDS (Drug)
Donepezil TDS Buttock
Corplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days)
干预措施: Donepezil TDS (Drug)
Donepezil TDS Leg
Corplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days)
干预措施: Donepezil TDS (Drug)
结局指标
主要结局
Pharmacokinetics, CMAX
时间窗: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Peak Plasma Concentration (Cmax) of once-weekly Corplex Donepezil TDS applied to different body locations.
Pharmacokinetics, AUC
时间窗: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Area under the plasma concentration versus time curve (AUC) of once-weekly Corplex Donepezil TDS applied to different body locations.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Daily during 1 week treatment period throughout the 5 week period)
- Application Site Mean Adhesion Scores of Donepezil Corplex TDS(Daily during 1 week treatment period)
- Summary Listing of Skin Irritation Score of Donepezil Corplex TDS by post-removal time point(0.5hr, 24hr, 48hr and 72hr after each TDS removal. (3 days))