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 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT03603132
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old
2. The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
3. Signed informed consent.
Exclusion Criteria:
1. Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
2. Having deep vein thrombosis or other thrombotic diseases.
3. Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
4. Extended QT interval during the screening period (calculated in Bazett's method, males \>450 msec)
5. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.
6. Those who have a history of allergies to drugs , food or test drugs or similar drugs;
7. Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study
8. Those who took any drug within 14 days before the test (including Chinese herbal medicine)
9. Any drug that inhibits or induces liver drug metabolism within 30 days before the test
10. Subjects have participated in other clinical trial within the 3 months prior to study entry.
11. One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03603132
Study Brief:
Protocol Section:
NCT03603132