Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).

Dongkook Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: DKF-310; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02695004

DKF-310-P1

Details and patient eligibility

About

This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.

Enrollment: 44 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 5 patient groups

Donepezil 35 mg

Experimental group

Description:

Donepezil 35 mg or placebo

Treatment:

Drug: Placebo

Drug: DKF-310

Donepezil 70 mg

Experimental group

Description:

Donepezil 70 mg or placebo

Treatment:

Drug: Placebo

Drug: DKF-310

Donepezil140 mg

Experimental group

Description:

Donepezil 140 mg or placebo

Treatment:

Drug: Placebo

Drug: DKF-310

Donepezil 210 mg

Experimental group

Description:

Donepezil 210 mg or placebo

Treatment:

Drug: Placebo

Drug: DKF-310

Donepezil 280 mg

Experimental group

Description:

Donepezil 280 mg or placebo

Treatment:

Drug: Placebo

Drug: DKF-310