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

Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02695004

Enrollment

Registered

2016-03-01

Start date

2016-02-29

Completion date

2017-03-31

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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

Interventions

DRUGDKF-310

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026