A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects
- Registration Number
- NCT01860625
- Lead Sponsor
- Icure Pharmaceutical Inc.
- Brief Summary
Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1(12.5㎠) Donepezil patch drug : 9 people, 43.75mg/12.5㎠ placebo : 3 people, 12.5㎠ 1(12.5㎠) placebo drug : 9 people, 43.75mg/12.5㎠ placebo : 3 people, 12.5㎠ 2(25㎠) Donepezil patch drug : 9 people, 87.5mg/25㎠ placebo : 3 people, 25㎠ 2(25㎠) placebo drug : 9 people, 87.5mg/25㎠ placebo : 3 people, 25㎠ 3(50㎠) placebo drug : 9 people, 175mg/50㎠ placebo : 3 people, 50㎠ 3(50㎠) Donepezil patch drug : 9 people, 175mg/50㎠ placebo : 3 people, 50㎠
- Primary Outcome Measures
Name Time Method safety and tolerability evaluation -1d~20d evaluation item
1. adverse event
2. electrocardiographie
3. vital sign
4. physical examination
5. urine, blood test
6. skin irritation
- Secondary Outcome Measures
Name Time Method 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 evaluation item : donepezil conc.
evaluation variable
* AUC last, AUC0-∞, Cmax, tmax, t1/2β, CL/F
Trial Locations
- Locations (1)
ASAN Medical Center
🇰🇷Seoul, Korea, Republic of