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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT03726866
Eligibility Criteria:
Inclusion Criteria:
1. Healthy volunteers aged between ≥ 19 and ≤ 40 years old
2. Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
3. Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
4. Subject who agree not to provide sperm
5. Subject who voluntarily agree to participate in this study
Exclusion Criteria:
1. Any medical history that may affect drug absorption, distribution, metabolism and excretion
2. Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
3. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
4. Subject who have received other clinical trial drugs within 90 days prior to the screening visit
5. Any clinically significant active chronic disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
40 Years
Study:
NCT03726866
Study Brief:
Protocol Section:
NCT03726866