A Phase 1, Open-Label, 3-Period, Randomized, Crossover Pharmacokinetic Study to Evaluate the Steady-State Pharmacokinetics of 5 mg and 10 mg Corplex™ Donepezil Transdermal Delivery Systems Compared to 10 mg Oral Administration of Aricept® in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Corium, Inc.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum Concentration (Cmax)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
open label
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females.
- •Subject's Body Mass Index (BMI) must be between 18 and 32 kg/m2 (inclusive).
- •Subject must be continuous non-smokers.
- •Subject must have a Fitzpatrick skin type of I, II or III.
排除标准
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- •After resting seated for at least 3 minutes, subjects should be excluded from the study with the following vital signs at Screening
- •systolic blood pressure outside the range of 90-145 mmHg, or
- •diastolic blood pressure outside the range of 50-90 mmHg, or
- •resting heart rate outside the range of 40-100 beats per minute.
- •Has an isolated ALT ≥1.5x the ULN or AST ≥1.5x the ULN at Screening; or both ALT and AST exceeding the ULN.
- •Estimated creatinine clearance at screening <70 mL/min/1.73 m
- •Prolonged corrected QTcF on screening ECG (≥450 ms for both females and males).
- •History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with patch adhesion or 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 skin tolerability assessments
- •Use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration.
- •Has participated in another clinical trial within 30 days prior to Day -1.
研究组 & 干预措施
Treatment A
5 mg/day Donepezil Transdermal Delivery System (TDS) 1-week wear and applied weekly for 5 consecutive weeks
干预措施: Donepezil TDS (Combination Product)
Treatment B
10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks
干预措施: Donepezil TDS (Combination Product)
Treatment C
10 mg/day Aricept® donepezil tablet administered QD for 5 consecutive weeks
干预措施: Aricept (Drug)
结局指标
主要结局
Maximum Concentration (Cmax)
时间窗: 35 days of each Treatment
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
Area Under the Curve (AUC)
时间窗: 35 days each Treatment
To evaluate steady-state donepezil plasma exposure (AUC) following 5 weeks of treatment
次要结局
未报告次要终点