Trial | NCT01860625  Report issue

Title

A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    donepezil ...

  • Study Participants

    36
Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.
Study Started
Apr 30
2013
Primary Completion
Dec 31
2013
Study Completion
Feb 28
2014
Last Update
Jun 30
2014
Estimate

Drug Donepezil patch

Drug placebo

1(12.5㎠) Experimental

drug : 9 people, 43.75mg/12.5㎠ placebo : 3 people, 12.5㎠

2(25㎠) Experimental

drug : 9 people, 87.5mg/25㎠ placebo : 3 people, 25㎠

3(50㎠) Experimental

drug : 9 people, 175mg/50㎠ placebo : 3 people, 50㎠

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.
No Results Posted