A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects
NCT ID: NCT01860625
Last Updated: 2014-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2013-04-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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1(12.5㎠)
drug : 9 people, 43.75mg/12.5㎠
placebo : 3 people, 12.5㎠
Donepezil patch
placebo
2(25㎠)
drug : 9 people, 87.5mg/25㎠
placebo : 3 people, 25㎠
Donepezil patch
placebo
3(50㎠)
drug : 9 people, 175mg/50㎠
placebo : 3 people, 50㎠
Donepezil patch
placebo
Interventions
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Donepezil patch
placebo
Eligibility Criteria
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Inclusion Criteria
* Systolic blood pressure : more than 90, less than 140 (mmHg)
* Diastolic blood pressure : more than 60, less than 100 (mmHg)
Exclusion Criteria
* 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.
20 Years
45 Years
MALE
Yes
Sponsors
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Icure Pharmaceutical Inc.
INDUSTRY
Responsible Party
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Locations
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ASAN Medical Center
Seoul, , South Korea
Countries
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References
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Choi HY, Kim YH, Hong D, Kim SS, Bae KS, Lim HS. Therapeutic dosage assessment based on population pharmacokinetics of a novel single-dose transdermal donepezil patch in healthy volunteers. Eur J Clin Pharmacol. 2015 Aug;71(8):967-77. doi: 10.1007/s00228-015-1875-2. Epub 2015 May 28.
Other Identifiers
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IPI-001
Identifier Type: -
Identifier Source: org_study_id