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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT03809260
Eligibility Criteria:
Inclusion Criteria:
* Age between 19 to 45, healthy male subjects(at screening)
* Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Exclusion Criteria:
* Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
* Serum AST(SGOT), ALT(SGPT)\>1.5 times upper limit of normal range
* MDRD eGFR \<80mL/min/1.73m2
* Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 3 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
45 Years
Study:
NCT03809260
Study Brief:
Protocol Section:
NCT03809260