Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).
NCT ID: NCT02695004
Last Updated: 2020-04-06
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
44 participants
INTERVENTIONAL
2016-02-29
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Donepezil 35 mg
Donepezil 35 mg or placebo
DKF-310
Placebo
Donepezil 70 mg
Donepezil 70 mg or placebo
DKF-310
Placebo
Donepezil140 mg
Donepezil 140 mg or placebo
DKF-310
Placebo
Donepezil 210 mg
Donepezil 210 mg or placebo
DKF-310
Placebo
Donepezil 280 mg
Donepezil 280 mg or placebo
DKF-310
Placebo
Interventions
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DKF-310
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight 55 to 90 kg and BMI 18.0 to 27.0
* Voluntarily signed the informed consent form
* Eligible according to the screening test results
* Available to follow up after drop-out
Exclusion Criteria
* Hypersensitivity to donepezil, piperidine derivatives and other drugs
* SBP \<100 mmHg or \>150 mmHg, or DBP \<60 mmHg or \>100 mmHg
* Skin and muscle disorders or history of surgery at the injection site
* AST or ALT \>1.5xULN; QT/QTcB interval \>450 ms
* History or positive result of drug abuse
* Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week
* Participated in other clinical trials within 3 months
* Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month
* Alcohol consumption \>21 units/week
* Smoked \>10 cigarettes/day within 3 months
* Caffeine-containing foods
* Not eligible due to other reasons at the investigator's discretion
19 Years
50 Years
MALE
Yes
Sponsors
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Dongkook Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Seoul National Univ. Bundang Hospital
Seongnam, , South Korea
Countries
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Other Identifiers
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DKF-310-P1
Identifier Type: -
Identifier Source: org_study_id
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