A Phase 1, 2-Way Crossover Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil 5 mg Transdermal Delivery System (TDS) 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
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics, AUC
研究概览
简要总结
A study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
详细描述
2-Way Crossover study
Approximately 24 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application in treatment period 1.
For each treatment period, subjects will have one 7-day TDS applied on their back. Depending on which sequence a subject is randomized to, the healthy subject will either be exposed to heat or not during the TDS wear time.
Blood samples for Donepezil PK will be collected pre-dose until the end of each treatment period.
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 ≥ 30 years of age
排除标准
- •History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study
- •History or presence of alcoholism or drug abuse within the past 2 years prior to the first study product treatment
- •History or presence of hypersensitivity or idiosyncratic reaction to the study products or related compounds
- •History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs
- •History or presence of excessive sweating
- •History or presence of hairy skin on application sites
- •History or presence of significant skin damage or disease at application sites
- •Any medical or surgical procedure or trauma within 28 days prior to the first study product treatment
研究组 & 干预措施
Donepezil TDS with Heat Applied
Corplex Donepezil TDS 5 mg/day with heat applied
干预措施: Donepezil TDS (Drug)
Donepezil TDS without Heat
Corplex Donepezil TDS 5 mg/day with no heat applied
干预措施: Donepezil TDS (Drug)
Donepezil TDS Extension Study with Heat
Corplex Donepezil TDS 5 mg/day with heat. Two skin sensors will be placed underneath the TDS and adjacent to the TDS.
干预措施: Donepezil TDS (Drug)
结局指标
主要结局
Pharmacokinetics, AUC
时间窗: Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Area under the curve (AUC) of once-weekly Donepezil TDS in the presence and absence of heat
Pharmacokinetics, Cmax
时间窗: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Peak plasma concentration (Cmax) of once-weekly Donepezil TDS in the presence and absence of heat
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Daily during 1 week treatment period and during the 5 week follow-on period)
- Summary Listing of Skin Irritation Score of Donepezil TDS by post-removal time point(0.5 hr, 24 hr, 48 hr, 72 hr after each TDS removal (3 days))
- Application Site Mean Adhesion Scores of Donepezil TDS(Daily during 1 week treatment period)