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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT07265466
Eligibility Criteria:
Inclusion Criteria:
* Healthy subject aged ≥ 19 years to \< 65 years at the time of screening
* Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
* Subjects who have voluntarily decided to participate after fully understanding the clinical trial based on the detailed explanation given, and have provided written informed consent before the screening procedure.
Exclusion Criteria:
* Subject who has a clinically significant history of disease in the liver, kidneys, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hematopoietic and oncological system, or cardiovascular system.
* The Subject who has a clinically significant bleeding or a history of congenital or acquired bleeding disorders such as hemophilia
* Subject who has a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia repair, endoscopic polypectomy, or hemorrhoidectomy, fissure, or fistula surgery) that may affect the absorption of the investigational product.
* The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).
* Screening laboratory test showing any of the following abnormal laboratory results
* Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
64 Years
Study:
NCT07265466
Study Brief:
Protocol Section:
NCT07265466