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 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT07231861
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults aged 19 years or older at the time of screening.
* Body mass index (BMI) between 18 and 30 kg/m².
* Male subjects: body weight ≥ 50 kg.
* Female subjects: body weight ≥ 45 kg.
* Clinically healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, as determined by the investigator.
* Willing and able to provide written informed consent after receiving a full explanation of the study.
* Subjects (and their partners, if applicable) agree to use highly effective, non-hormonal contraception from the first dosing day until one week after the last dose.
Exclusion Criteria:
* Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
* Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
* Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
* History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
* Known hypersensitivity to the investigational product or its components.
* Known metabolic or genetic disorders such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or phenylketonuria.
* History of clinically significant psychiatric illness.
* Pregnant or breastfeeding women, or women with a possibility of pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07231861
Study Brief:
Protocol Section:
NCT07231861