Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT02695004
Eligibility 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT02695004
Study Brief:
Protocol Section:
NCT02695004