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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT04639804
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult aged ≥ 19 and \< 55 year-old at screening
* Body mass index (BMI) ≥ 19.0 kg/m2 and \< 27.0 kg/m2 with a body weight ≥ 55 kg at screening.
Exclusion Criteria:
* History or evidence of clinically significant disease
* History of GI disease or surgery that may affect the absorption of a drug
* Laboratory test result which falls into the following values( ALT or AST \> 2 × upper limit of normal (ULN))
* History of regular alcohol consumption exceeding 210 g/week within 6 months
* Daily use of ≥ 20 cigarettes within 6 months
* Has taken any investigational agent within 6 months prior to the first dose of IMP
* Subjects who are considered ineligible to participate in this study at the discretion of the investigator.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT04639804
Study Brief:
Protocol Section:
NCT04639804