influenza
Conditions
Interventions
Cases:Lianhua qingwen capsule 12, many times to drug
Sponsors
Ethics committee of Hebei Yiling Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. healthy volunteers aged 18 to 45 (including 18 years old) or those having their appendix removed; 2. the body weight of male subjects should be >=50 kg and that of female subjects should be >=45kg; Body mass index (BMI = weight (kg)/height (m) squared) was between 19 and 26 (with the cutoff); 3. subjects understand and accept the procedures and restrictions of this study, voluntarily participate in this clinical study, and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. patients with a history of heart, liver, lung, kidney, endocrine, metabolic, blood and nervous system diseases that were clinically significant by the researchers within 6 months before taking the drug; 2. patients with gastrointestinal diseases and other medical history within 6 months before taking the medicine (except those with appendicitis leading to appendectomy) or gastrointestinal discomfort before taking the medicine; 3. liver and kidney damage; 4. subjects who are known to be allergic to the ingredients or products of lianhua qingwen capsule and allergic conditions (including allergic reactions to other drugs); 5. taking drugs and antibiotics that are known to cause damage to a certain organ within 3 months, taking various drugs within 2 weeks and taking research drugs within 4 weeks; 6. have taken special diet (including dragon fruit, mango, grapefruit, etc.) or other factors affecting drug absorption, distribution, metabolism and excretion within two weeks before taking the drug; 7. does not agree to avoid tobacco, alcohol, or the use of chocolate, yogurt, any dairy products, foods, or beverages containing caffeine or xanthine or probiotics for 48 hours prior to and during the trial, or does not agree to avoid strenuous exercise; 8. abnormal vital signs (systolic blood pressure >=140mmHg or =90mmHg or < 60mmHg); 9. comprehensive physical examination, blood biochemistry, blood routine, urine routine, electrocardiogram and chest X-ray during the screening period indicated that the subjects had abnormalities that were judged by the researchers to be of clinical significance; 10. those with positive results in screening serological examination (HBsAg, anti-hcv, anti-hiv or tppa-ab); 11. smoking more than 1 cigarette per day within 3 months before screening; 12. those whose alcohol intake averaged more than 14 units per week (1 unit =10 mL ethanol, i.e. 1 unit = 5% beer or 25 mL spirits or 83 mL wine) or who tested positive for alcohol in the 3 months prior to screening; 13. those with a history of drug dependence or drug abuse within 12 months prior to screening, or those with positive test results of addictive substances during screening; 14. patients with needle sickness, blood sickness and moderate anemia (hemoglobin less than 100g/L); 15. those who have special requirements for diet and cannot follow a uniform diet; 16. patients who had experienced blood loss or blood donation =200mL or donated 1 unit of blood within 3 months before the first administration of the drug; 17. have participated in any clinical trial as a subject within 3 months prior to the first administration of the drug; 18. the subject has a birth plan or plans to donate sperm and eggs within half a year. Women who are pregnant or lactating, or who are positive in pregnancy during the screening period or before the first administration of the drug in the trial, or who are unable or fail to take effective contraceptive measures approved by the researcher during the study as directed by the researcher; 19. other factors considered unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;T1/2; | — |
Countries
China
Contacts
Public ContactYuqin Hu
Hebei Yiling Hospital
Outcome results
None listed