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← Trials/Trial dossier/NCT01860625

CompletedPhase 1

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

Asset

Donepezil

Listed sites

1

Recruiting sites

-

Enrollment

36

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 20-45•Male

Primary endpoint

•Safety and tolerability evaluation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIPI-001
NCT IDNCT01860625

Timeline

Milestones

Study start2013-04 (month precision)
Study first posted2013-05-23estimated
Primary completion2013-12actual (month precision)
Study completion2014-02actual (month precision)
Last update posted2014-06-30estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

safety and tolerability evaluation

Time frame:-1d~20d

event count, event

Secondary/protocol endpoint

pharmacokinetics characteristic evaluation

Time frame:1d 0h(before administration), (after administration)4h, 8h, 12h, 24h, 48h, 70h, 72h, 74h, 76h, 80h, 96h, 120h, 144h, 168h, 216h, 264h, 312h

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.