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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03977805
Eligibility Criteria:
Inclusion Criteria:
* Health male subjects, age between 18-45 years.
* BMI between 19 and 26 kg/m2 .
* Signed informed consent.
Exclusion Criteria:
* Abnormal results in physical examination、laboratory tests、X-ray、abdominal ultrasound、echocardiography have clinical significance.
* Abnormal platelet counts or platelet aggregation has clinical significance.
* Abnormal troponin examination has clinical significance.
* Abnormal ophthalmic examination has clinical significance.
* Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody is positive.
* Those who have a history of allergies to test drugs or similar drugs.
* Those who have undergone surgery within 6 months prior to the trial .
* Those who took any drug within 14 days before the test (including Chinese herbal medicine).
* Any drug that inhibits or induces liver drug metabolism within 30 days before the test.
* Subjects who have participated in other clinical trial within the 3 months prior to study entry.
* One or more non-pharmacological contraceptive measures cannot be used during the trial or it is planned to have birth within one year.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03977805
Study Brief:
Protocol Section:
NCT03977805