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 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT05418803
Eligibility Criteria:
Inclusion Criteria:
* Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
* Acceptable medical history, physical examination, laboratory tests and EKG, during screening
* Subjects who has signed a written informed consent voluntarily
Exclusion Criteria:
* History of clinically significant medical history or current disease
* Hypotension (SBP ≤ 90 mmHg or DBP ≤ 60 mmHg) or hypertension (SBP
≥ 140 mmHg or DBP ≥ 90 mmHg).
* AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit
* Total bilirubin \> 2.0 mg/dl
* Volunteers considered not eligible for the clinical trial by the investigator
* Administration of other investigational products within 6 month prior to the first dosing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT05418803
Study Brief:
Protocol Section:
NCT05418803