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.
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0001323
- Lead Sponsor
- Icure Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 24
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety and tolerability
- Secondary Outcome Measures
Name Time Method pharmacokinetics characteristic