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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02178124

Enrollment

Registered

2014-06-30

Start date

2014-07-31

Completion date

2014-12-31

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects

Interventions

DRUGDonepezil

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
safety and tolerability evaluation	patch : -1d~33d, oral : -1~11d	evaluation item 1. adverse event 2. electrocardiographie 3. vital sign 4. physical examination 5. urine, blood test 6. skin irritation

Secondary

Measure	Time frame	Description
pharmacokinetics characteristic evaluation	patch: -1~25d, oral -1~11d	cohort 1 1d 0h (pre-dose), 4h, 8h, 12h, 24h (2d), 48h (3d), 72h (4d), 144h (7d), 216h (10d), 288h (13d, last dose start), 292h, 296h, 300h, 312h (14d), 336h (15d), 360h (16d, patch removal), 362h, 364h, 368h, 372h, 384h (17d), 408h (18d), 432h (19d), 480h (21d), 528h (23d), 576h (25d) cohort 2 1 period Oral Donepezil 1d 0h (pre-dose), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 8h, 12h, 24h (2d), 48h (3d), 96h (5d), 144h (7d), 192h (9d), 240h (11d) period 2 Donepezil Patch: same cohort1 evaluation item : donepezil conc. evaluation variable patch : AUCτ,ss, Cmax,ss, t1/2β, AI (accumulation index), Cav,ss oral : AUClast, AUC0-∞, Cmax, tmax, t1/2β, CL/F

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026