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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT06154434
Eligibility Criteria:
Main Inclusion Criteria:
1. Healthy subjects, over the age of 19 years old
2. Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2.
3. All subjects should be judged normal and healthy during a pre-study medical evaluation
* Subjects who has no birth or chronic disease and must be in good health as determined by physical exmination and medical tests including biochemistry, urinalysis, serology and hematology etc in serum/urine.
4. Subject is willing to participate and to Sign written informed consent form
5. Female subjects of childbearing age who use contraception other than hormonal contraception.
6. Subjects who has no history of psychical disorder within the last five years
Main Exclusion Criteria:
1. Subjects who have a medical history specified in protocol
2. Subjects who are expected to have the prohibited medication and activity etc. during the study period
3. Subjects who can not comply with requirements as per protocol
4. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
5. Subjects who are not suitable for the clinical trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06154434
Study Brief:
Protocol Section:
NCT06154434