KCT0001323已完成未知
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.
Icure Pharmaceuticals0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1)Aged 20 to 45 years at screening visit
- •2)Having a Body Mass Index (BMI) between 19 and 27kg / m² (inclusive) at the screening visit
- •3)Subjects who meet the following range of sitting blood pressure at the screening visit,
- •Systolic blood pressure; 90 mmHg to 140 mmHg
- •Diastolic blood pressure; 60 mmHg to 100 mmHg
- •4)Subjects who voluntarily signed informed consent to participate in the study and comply with the clinical trial procedures.
排除标准
- •1)Subjects with clinically significant disease or a medical history of hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neuropsychiatric, hematologic-oncologic, cardiovascular system disease (especially in subjects with a medical history of asthma, obstructive pulmonary disease, gastric ulcer)
- •2)Subjects with a skin disease or a medical history of skin graft surgery that might affect the absorption of the investigational product
- •3)Subjects with hypersensitivity or medical history of clinically significant hypersensitivity to Donepezil component or family series of Donepezil components or the other drugs (such as aspirin, antibiotics, etc.) (but, except inactive allergic rhinitis)
- •4)Subjects with a history of Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •5)Subjects with a history of drug abuse or with positive result for urine drug test concerns about drug abuse and misuse
- •6)Subjects who took another investigational product within 60 days before the screening visit
- •7)Receipt of a drugs, within 30days before the screening visit, which affect the absorption or elimination processes of drug chronically
- •8)Whole blood donation within 60 days or apheresis within 30 days or transfusion within 30 days prior to the screening visit
- •9)Subjects with clinically significant disease within 30 days before the screening visit
- •10)Subjects who took ETC (Ethical Drug) within 30 days or took OTC drug or herbal medicine (including Chinese medicines) within 14 days before the screening visit (but, subjects who are judged by the investigator to be appropriate in the other criteria of the study, can participate in this study)
- •11)Subjects having abnormal eating habits that affect the absorption, distribution, metabolism, and excretion (ADME) of drugs within 30 days before the screening visit
- •12)Subjects with a history of alcohol abuse within 2 years before the screening visit
- •13)Heavy smoker (more than 10 cigarettes / day)
- •14)Subjects with liver enzyme levels (AST, ALT) or CK (Creatine Kinase) higher than 2.5 times the upper normal limit (UNL), or total serum bilirubin (total bilirubin) is higher than 1.5 times the upper normal limit (UNL) at the screening visit test
- •15)Subjects with a positive serologic test
- •16)Subjects with QTc > 450 msec on ECG performed during the screening period
- •17)Subjects who are ineligible to participate in the trial according to the investigator’s clinical decision based on diagnostic tests results such as laboratories; hematology, routine chemistry, urinalysis, clinical chemistry urinalysis, etc. (except exclusion criteria No.14), physical examinations, vital signs (except inclusion criteria No.3), and ECG(except exclusion criteria No.16), etc.
- •18)Any other reason, in the opinion of the investigator, may either put the subjects at risk because of the participation in the study, or may influence the result of the study
研究者
相似试验
招募中
不适用
The evaluation of safety, tolerability and pharmacokinetics of stroke targeting drug in healthy volunteersDiseases of the nervous systemKCT0000936Jeil Pharmaceutical56
已完成
不适用
A phase I, single-centre, randomised, single-blinded, placebo-controlled single ascending dose study, followed by an open-label extension, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of ALX 0651, administered intravenously to healthy male volunteers.NL-OMON35929Ablynx NV76
已完成
1 期
A study to investigate the safety, tolerability and activity of multiple ascending doses of DNDI-0690 in healthy volunteers including assessment of heart and kidney functioThe safety, tolerability and fluid exposure of a drug aimed to treat visceral and cutaneous leishmaniasis in healthy volunteersISRCTN30122193Drugs for Neglected Diseases Initiative45
已完成
1 期
A study to assess safety, drug levels in blood and markers of immune system response after an escalating single dose of a new compound developed for the treatment of cutaneous leishmaniasis, CpG-ODN-D35, in healthy male subjectsCutaneous leishmaniasisInfections and InfestationsISRCTN15458851Drugs for Neglected Diseases Initiative54
已完成
1 期
A Phase 1, Safety and Pharmacokinetic Study of CSL312 in Healthy SubjectsHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersInflammatory and Immune System - Other inflammatory or immune system disordersHereditary AngioedemaACTRN12616001438448CSL Limited48