A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects | NCT01860625 | Trialant
CompletedInterventionalPhase 1Updated Jun 30, 2014
A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects
ClinicalTrials.gov ID
NCT01860625
Lead Sponsor
Icure Pharmaceutical Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
36Actual
Last Update Posted
Jun 30, 2014Estimated
Start Date
Apr 2013
Primary Completion Date
Dec 2013Actual
Completion Date
Feb 2014Actual
Brief Summary
Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.
Alzheimer Disease
Donepezil patch
placebo
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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.