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

Icure Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: placebo; Drug: Donepezil patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01860625

IPI-001

Details and patient eligibility

About

Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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36 participants in 3 patient groups

1(12.5㎠)

Experimental group

Description:

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

Treatment:

Drug: placebo

Drug: Donepezil patch

2(25㎠)

Experimental group

Description:

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

Treatment:

Drug: placebo

Drug: Donepezil patch

3(50㎠)

Experimental group

Description:

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

Treatment:

Drug: placebo

Drug: Donepezil patch