NCT01860625已完成1 期
A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- safety and tolerability evaluation
研究概览
简要总结
Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI : more than 20 ㎏/㎡, less than 26 ㎏/㎡
- •Systolic blood pressure : more than 90, less than 140 (mmHg)
- •Diastolic blood pressure : more than 60, less than 100 (mmHg)
排除标准
- •Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease.
- •A history of skin disease or skin graft
- •Hypersensitivity to donepezil or piperidine derivatives or any of the excipients.
- •A known or suspected history of drug or alcohol dependency or abuse
- •Patients who have participated in another clinical study within 60 days.
- •Whole blood within 60 days, apheresis within 30 days, transfusion within 30 days
- •Heavy caffeine intake(more than 5 units/day)
- •Heavy alcohol intake(more than 21 units/week)
- •Heavy smoker(more than 10 cigarette/day)
- •Abnormal clinical laboratory values which are judged clinically significant by the investigator.
- •Any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
研究组 & 干预措施
1(12.5㎠)
Experimental
drug : 9 people, 43.75mg/12.5㎠
placebo : 3 people, 12.5㎠
干预措施: Donepezil patch (Drug)
1(12.5㎠)
Experimental
drug : 9 people, 43.75mg/12.5㎠
placebo : 3 people, 12.5㎠
干预措施: placebo (Drug)
2(25㎠)
Experimental
drug : 9 people, 87.5mg/25㎠
placebo : 3 people, 25㎠
干预措施: placebo (Drug)
3(50㎠)
Experimental
drug : 9 people, 175mg/50㎠
placebo : 3 people, 50㎠
干预措施: placebo (Drug)
3(50㎠)
Experimental
drug : 9 people, 175mg/50㎠
placebo : 3 people, 50㎠
干预措施: Donepezil patch (Drug)
2(25㎠)
Experimental
drug : 9 people, 87.5mg/25㎠
placebo : 3 people, 25㎠
干预措施: Donepezil patch (Drug)
结局指标
主要结局
safety and tolerability evaluation
时间窗: -1d~20d
evaluation item 1. adverse event 2. electrocardiographie 3. vital sign 4. physical examination 5. urine, blood test 6. skin irritation
次要结局
- pharmacokinetics characteristic evaluation(1d 0h(before administration), (after administration)4h, 8h, 12h, 24h, 48h, 70h, 72h, 74h, 76h, 80h, 96h, 120h, 144h, 168h, 216h, 264h, 312h)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects.Alzheimer DiseaseNCT02178124Icure Pharmaceutical Inc.24
已完成
1 期
Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female SubjectsHealthyNCT02635750Boehringer Ingelheim32
招募中
1 期
Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male VolunteersAlzheimer DiseaseNCT06127368G2GBio, Inc.56
已完成
3 期
A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's DiseaseAlzheimer DiseaseNCT03197740Icure Pharmaceutical Inc.399
已完成
1 期
Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male VolunteersAlzheimer DiseaseNCT05525780G2GBio, Inc.48