Overview

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.

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
Male
Summary
Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Icure Pharmaceutical Inc.
Treatments:
Donepezil
Criteria
Inclusion Criteria:

- BMI : more than 19 ㎏/㎡, less than 27 ㎏/㎡

- 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 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.