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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT03639493
Eligibility Criteria:
Inclusion Criteria:
* Healthy males aged 20 to 45 years at screening
* BMI: 18 \~ 29.9kg/m\^2
* Body weight ≥ 50kg
* Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding
Exclusion Criteria:
* Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
* Subjects who have symptoms of an acute disease within 28 days before first administration
* Subjects who have clinically significant active, chronic disease
* Subjects who fall under the criteria below in laboratory test
* AST/ALT \> UNL (upper normal limit) x 2
* Total bilirubin \> UNL x 1.5
* CrCL \< 50mL/min
* CPK \> UNL x 2.5
* Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)
* Subjects with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT03639493
Study Brief:
Protocol Section:
NCT03639493