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.