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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT04673695
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood coagulation, blood chemistry, serology, urinalysis) at screening.
5. Those who agree to contraception during the participation of clinical trial.
6. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion Criteria:
1. Those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeleto-muscular, immune, etc.
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.
4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
5. Those who donated whole blood within 2 months or blood components within 1 month prior to the first dose of the investigational product.
6. Those who exceed an alcohol and cigarette consumption than below criteria. A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week B. Smoking: 20 cigarettes/day
7. Those who exceeds 2 times the upper limit of the reference range of AST(or ALT) or 1.5 times the upper limit of the reference range of γ-GTP.
8. Those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions.
9. Those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.)
10. Those who were deemed inappropriate to participate in the study by the investigator.
11. Those who have a pregnant or nursing woman.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04673695
Study Brief:
Protocol Section:
NCT04673695