Undetermined
Conditions
Interventions
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects who voluntarily participate in the trial and sign the informed consent can complete the trial according to the requirements of the protocol; 2. There is no limit to men and women. The age of informed consent is 18-70 years old (including the critical value); 3. Body mass index (BMI) >= 18.0 and = 45 kg at the time of screening; 4. Subjects who have no history of heart, liver, kidney, digestive tract, nervous system diseases and metabolic abnormalities with clinical significance after medical history inquiry, or chronic diseases that do not affect the experimental observation judged by research doctors, etc; 5. Subjects with normal or abnormal results of vital signs, physical examination, laboratory examination and ECG examination but without clinical significance judged by the research doctor; 6. Subjects with good venous conditions can establish blood collection channels according to the research plan; 7. Subjects who had no family planning during the study period planned to use reliable contraceptives during the study period until 3 months after the last administration of the trial drug, and had no sperm donation plan.
Exclusion criteria
Exclusion criteria: 1. Subjects with weakness of spleen and stomach, cold constitution or yang deficiency, Qi deficiency and dampness, wind cold and cold; 2. Subjects with relatively high background of baicalin and baicalein in blood; 3. Subjects taking any prescription drugs (except vaccine), Chinese herbal medicine, over-the-counter drugs (except occasional and restricted use of paracetamol) and health products (except routine supplementary vitamins) within 2 weeks before administration; 4. Subjects with positive results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or Treponema pallidum antibody during screening; 5. Patients with any history of malignant tumor; 6. Subjects who participated in the clinical study of any drug or device within 3 months before administration; 7. Subjects who donated more than or equal to 400 ml blood within 3 months before administration, or who lost more than or equal to 400 ml blood for any reason; 8. Subjects who are known to be allergic to the test drug or its excipients; 9. Subjects who frequently drank alcohol within 3 months before administration, i.e. subjects who drank more than 21 units of alcohol per week (1 unit = 360 ml beer or 45 ml 40% alcohol or 150 ml wine), or whose alcohol breath test was positive; 10. Subjects with positive urine drug screening; 11. Subjects who smoked more than 10 cigarettes per day within 3 months before administration, or failed to comply with the no smoking regulations during the trial; 12. The subjects had any factors that the research doctor thought were not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| baicalin and baicalein; | — |
Countries
China
Contacts
Public ContactChen Yu, Gangyi Liu
Shanghai Xuhui Central Hospital
Outcome results
None listed