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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT05812404
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults aged ≥ 19 and ≤ 50 years at screening
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
Exclusion Criteria:
* Subjects with a disease or a history related to hepatobiliary system, kidney(severe kidney disorder ect.), nervous system, respiratory system, digestive system, endocrine system, hematology system, circulatory system(Heart failure, Torsades de pointes ect.), unrinary system, psychiatry ect.
* Subjects with digestive disease(gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal disease, Crohn's disease) or history of surgery(except appendectomy, hernia surgery) which can affect on saftey and pharmacodynamics
* Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker \[P-CAB\] class, aspirin, antibiotics, etc.
* Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
* Subjects with history of inherited muscle disorders
* Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
* Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
* Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
* Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration
* Subjects who are unable to refrain from smoking(\>10pieces/day) from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects with alchoholic disorders or subjects who are unable to refrain from drinking(\>21units/week) from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects who are unable to refrain from caffein(\>5units/day) from 3 days prior to the first scheduled dose until last discharge from hospital
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT05812404
Study Brief:
Protocol Section:
NCT05812404