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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT05034120
Eligibility Criteria:
Inclusion Criteria:
* Subject who meet all of the requirements as follows will be included.
1. Healthy male or female subjects aged 18 to 65 (including 18 and 65);
2. Male weight ≥50 kg, female weight ≥45 kg, body mass index in the range of 18-28 kg/m2 (including 18 and 28);
3. No medical history of mental abnormalities, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
4. Subjects agree to use effective contraceptive methods, such as condoms, contraceptive sponges, contraceptive gels, contraceptive membrane, intrauterine device, oral or injectable contraceptives, subcutaneous implants, or other contraceptive methods, from screening (2 weeks prior to screening for female subjects) to 6 months after the last dose;
5. The subject can have a good communication with the investigators, understand and comply with the requirements of this study, understand and sign the informed consent voluntarily.
Exclusion Criteria:
* Subject who meet either of the requirements as follows will be excluded.
1. Hypersensitivity (hypersensitivity to two or more substances) or known hypersensitivity to XZP-3621 tablets/similar drugs;
2. Abnormal examination during the screening period with clinical significance (to be determined by the investigator);
3. Frequent use of sedatives、sleeping pills or other addictive drugs et al;
4. Those who had a history of drug abuse or urine drug abuse screening positive within 12 months before enrollment;
5. Smoking more than 5 cigarettes a day, or failing to stop using any tobacco products during the test period;
6. Positive breath test for alcohol or regular drinkers in the 6 months prior to entry, i.e. drinking more than 3 units per day or more than 21 units per week (one unit is equivalent to a 350 mL bottle of beer or 120 mL of liquor or 30 mL of spirits (over 50°));
7. Take any prescription medicine or Chinese herbal medicine within 4 weeks before enrollment, and/or Take any over-the-counter (OTC) drug or food supplement (including vitamins, calcium tablets and other health care products) within 2 weeks before the first administration of XZP-3621 tablet;
8. Those who have participated in other clinical trials and taken experimental drugs within 3 months before enrollment;
9. Blood donation (including component blood donation) or blood loss of 400 mL within 3 months before enrollment, or blood transfusion;Blood donation (including component blood donation) or blood loss of 200 mL within 1 month before the test;
10. Have a history of major disease or major surgery or trauma 3 months before screening;
11. A history of gastrointestinal disease causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or a history of severe vomiting or diarrhea within the week prior to enrollment;
12. Female subjects during pregnancy and lactation and female subjects of childbearing age who cannot use contraception as required;
13. Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
14. Have special dietary requirements (including lactose intolerance) and fail to comply with the provided diet and corresponding regulations;
15. Subjects who are Dysphagia;
16. Subjects who refuse to stop any beverage or food containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, grapefruit and beverages containing this ingredient, etc.) 48 hours prior to first administration of XZP-3621 tablets until the end of the study.
17. Subjects who will refuse to discontinue any CYP3A4 inhibitors and inducers judged by the investigator within 7 days prior to the first administration of XZP-3621 tablets or within 5 half-lives of CYP3A4 inhibitors and inducers (whichever is longer) until the end of the study;
18. Subjects who are Inability to tolerate venipuncture or poor vascular status;
19. Subjects who are unsuitable to participate in this study judged by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05034120
Study Brief:
Protocol Section:
NCT05034120