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:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01829893
Eligibility Criteria:
Inclusion Criteria:
* Males age 20 to 45 years
* Body weight \> 50 kg with 18\~29 kg/m2 body mass index (BMI)
* Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations
Exclusion Criteria:
* subjects with acute conditions.
* presence of history affecting ADME
* Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
* Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
* Any other acute or chronic disease
* A history of hypersensitivity to donepezil
* A history of alcohol or drug abuse
* Participation in another clinical trial within 3 months
* smoked \>10 cigarettes daily
* consumption over 5 glasses daily of beverages containing xanthine derivatives
* use of any medication having the potential to affect the study results within 10 days before the start of the study.
* AST or ALT \> 1.25 of upper normal limit
* total bilirubin \> 1.5 of upper normal limit
* systolic blood pressure \< 90 mmHg
* calculated CLcr using Cockroft-Gault equation \< 50 mL/min
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01829893
Study Brief:
Protocol Section:
NCT01829893