Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).
- Registration Number
- NCT02695004
- Lead Sponsor
- Dongkook Pharmaceutical Co., Ltd.
- Brief Summary
This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 44
Inclusion Criteria
- Men aged 19 to 50 years
- 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
- Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Donepezil 70 mg DKF-310 Donepezil 70 mg or placebo Donepezil140 mg DKF-310 Donepezil 140 mg or placebo Donepezil 70 mg Placebo Donepezil 70 mg or placebo Donepezil 210 mg Placebo Donepezil 210 mg or placebo Donepezil 280 mg Placebo Donepezil 280 mg or placebo Donepezil 35 mg DKF-310 Donepezil 35 mg or placebo Donepezil 35 mg Placebo Donepezil 35 mg or placebo Donepezil 280 mg DKF-310 Donepezil 280 mg or placebo Donepezil140 mg Placebo Donepezil 140 mg or placebo Donepezil 210 mg DKF-310 Donepezil 210 mg or placebo
- Primary Outcome Measures
Name Time Method AUC 1056h 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h
Cmax 1056h 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National Univ. Bundang Hospital
🇰🇷Seongnam, Korea, Republic of