Influenza
Conditions
Interventions
Cases:Lianhua qingwen capsule 12, a single dose
Sponsors
Ethics committee of Hebei Yiling Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy volunteers, male, aged 18 to 45 years, han Chinese; 2) All subjects should weigh more than 50 kg and have a bmi between 18.5 and 26 (bmi = weight (kg)/height (m) squared); 3) The subjects understand and accept the procedures and restrictions of this study, voluntarily participate in this clinical study, and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with a medical history of heart, liver, lung, kidney, digestive tract, endocrine, metabolic, blood and nervous system diseases that the researcher has determined to be of clinical significance; 2) Liver and kidney function impairment; 3) The subject is known to be allergic to the components or products of lianhua qingwen capsule and allergic constitution (including allergic reaction to other drugs); 4) Have taken drugs that are known to damage certain organs within 3 months, have taken various drugs within nearly 2 weeks, and have taken the study drugs within 4 weeks; 5) Select those who have taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within the previous month; 6) Disagreeing to avoid using tobacco, alcohol, chocolate, caffeine or foods or drinks rich in xanthine within 48 hours before and during the study, or disagreeing to avoid strenuous exercise; 7) Patients with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; Heart rate 100 BPM); 8) During the screening period, comprehensive physical examination, blood biochemistry, blood routine, urine routine, electrocardiogram, chest X-ray and other indicators suggested that the subjects had abnormalities that were determined by the researchers to be of clinical significance; 9) Those with positive results of serological examination (HBsAg, anti-hcv, anti-hiv or tppa-ab) in the screening period; 10) Select those who smoke more than one cigarette per day in the first 3 months; 11) Select those whose alcohol intake in the first 6 months exceeds 14 units per week on average (1 unit =10 mL ethanol, that is, 1 unit =200ml beer with 5% alcohol content or 25 mL spirit with 40% alcohol content or 83 mL wine with 12% alcohol content) or who are tested positive for alcohol; 12) Those with a history of drug dependence or abuse in the first 12 months of screening, or those who have tested positive for addictive substances in screening; 13) Patients with needle sickness, blood sickness and moderate anemia (hemoglobin less than 100g/L); 14) Those who have special requirements on diet and cannot abide by the unified diet; 15) Patients who have lost blood or donated blood greater than or equal to 200ml or donated 1 unit of component blood within 3 months before the first administration of the drug; 16) Have participated in any clinical trial as a subject within 3 months prior to the first administration of the drug; 17) If the subject has a family planning or sperm donation plan within the past six months, or fails to take effective contraceptive measures approved by the researcher during the study period according to the researcher's guidance; 18) The researcher considers that the participant is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-t;AUC0-8;T1/2; | — |
Countries
China
Contacts
Public ContactYuqin Hu
Hebei Yiling Hospital
Outcome results
None listed