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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. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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.

NCT02178124•Icure Pharmaceutical Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

20 - 45 years

Sex

MALE

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.

Locations (1)

ASAN Medical Center

Seoul, South Korea

Key Dates

Start Date

July 1, 2014

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2014

Last Updated

March 25, 2015

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

Donepezil

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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.

Inclusion Criteria

Exclusion Criteria

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