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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT06437951
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adult volunteers aged 19 to 50 at the time of screening tests
2. Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
3. In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
4. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc
Exclusion Criteria:
1. Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
2. A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
4. A person who has been tested positive for Helicobacter pylori
5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT06437951
Study Brief:
Protocol Section:
NCT06437951