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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT05446233
Eligibility Criteria:
Inclusion Criteria:
* signing of informed consent
* Weight: Body mass index (BMI) is 19.0\~28.0 kg/m2
* Subjects are able to communicate well with the investigators and be able to complete the trial according to the process
Exclusion Criteria:
* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
* Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
* Positive results from urine drug screen test
* Donate blood or lose blood 400 mL or more within 3 month prior to dosing
* Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication
* History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05446233
Study Brief:
Protocol Section:
NCT05446233