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 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT05795192
Eligibility Criteria:
Inclusion Criteria:
* Healthy Korean or Caucasian adults between the ages of 19 and 50 as of the date of written consent
* Subjects with a body weight of 55.0 kg or more at the time of screening and a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2
* Written informed consent
Exclusion Criteria:
* Clinical significant medical history
* Gastrointestinal disease or past history
* Hypersensitivity or clinically significant hypersensitivity to the components of investigational drugs
* Screening test AST, ALT \> ULN x 1.5 Creatinine clearance \< 60mL/min/1.73m2 QTcB interval \> 450 ms Serologic test positive(Hepatitis B, Hepatitis C, HIV)
* SBP \<90 mmHg or \>150 mmHg, DBP \<60 mmHg or \> 100 mmHg
* Drub abuse history
* Administration of any OTC drug, Herbal drug, Investigational medication within 2weeks
* Participation in other clinical trial within 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT05795192
Study Brief:
Protocol Section:
NCT05795192