Status:
COMPLETED
A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects
Lead Sponsor:
Icure Pharmaceutical Inc.
Conditions:
Alzheimer Disease
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01860625
Start Date
April 1 2013
End Date
February 1 2014
Last Update
June 30 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ASAN Medical Center
Seoul, South Korea, 138-736