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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dongkook Pharmaceutical Co., Ltd.
• Treatments: Donepezil

Criteria

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