Chinese adult healthy volunteers
Conditions
Interventions
experimental group:Single oral Ainuovirine 150 mg on the first day, continuous oral rifampicin capsules 600 mg on days 4-20.
Sponsors
Shenzhen Third People's Hospital Medical
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Those who can fully understand the nature, methods, and possible reactions of this test, comply with the requirements listed in the informed consent form, and voluntarily sign the informed consent form; 2. Healthy subjects, aged 18 (inclusive) to 45 (inclusive) years old, both male and female; 3. Weight >= 50 kg and BMI index is 19-24 kg/m2 [BMI = weight/height^2]; 4. Comprehensive physical examination (including general physical examination, blood and urine routine, blood biochemical examination, chest X-ray, B-ultrasound and electrocardiogram, etc.), no serious liver and kidney damage, normal albumin value, and other indicators are in the basic normal range.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution or a history of allergy to the test drugs and excipients; 2. Currently suffering from more serious chronic diseases, metabolic diseases (such as diabetes), cardiovascular diseases, neurological and mental diseases; 3. Subjects with gastrointestinal dysfunction, or liver and kidney disease may interfere with the absorption, metabolism and/or excretion of the study drug; subjects with a history of cholecystectomy, peptic ulcer, inflammatory bowel disease or pancreatitis should be excluded. examinee; 4. Pregnant, breastfeeding women, women of childbearing age who cannot take effective contraceptive measures (such as contraceptive diaphragms; condoms; intrauterine devices, etc.; partner vasectomy) or their partners who cannot take effective contraceptive measures; 5. AST or ALT is greater than 1.25 times the upper limit of normal, and creatinine is greater than the upper limit of normal; 6. The platelet count is lower than the lower limit of normal; 7. Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive, syphilis titer positive, Covid-19 nucleic acid detection positive; 8. History of tuberculosis (TB) or lung disease; 9. Those who have taken coumarin anticoagulants or any other prescription drugs or plant compound preparations within 14 days before participating in this study, in addition, have taken any over-the-counter drugs or vitamin supplements within 7 days; 10. Those who have received the Covid-19 vaccine or other vaccines within 7 days before participating in this study; 11. Those who have participated in other clinical trials within 8 weeks before participating in this study; 12. Those who have donated or lost >= 400 ml of blood within 8 weeks before participating in this study; 13. Those who smoke >= 5 cigarettes per day; or who drink more than 14 units of alcohol per week (1 unit = 285 ml of beer; or 25 ml of spirits; or 1 glass of wine), or those who cannot smoke or drink during the test; 14. Those with a history of drug abuse; or those with positive urine drug screening; 15. Those who have special requirements for diet cannot comply with the provided diet and corresponding regulations. During the test, beverages or foods containing caffeine or xanthine or some fruits that may affect metabolism (mango, grapefruit, grapefruit, etc.) must be used; 16. Systolic blood pressure of 80-140 mmHg, or diastolic blood pressure of 60-85 mmHg; or heart rate outside the range of 50 to 100 beats per minute (bpm) (10 minutes of rest before measuring blood pressure and heart rate); 17. Those who cannot swallow the test drug according to the program requirements; 18. Those who are dizzy with needles and blood, cannot tolerate venipuncture or have difficulty in collecting blood; 19. The investigator judges that the person is not suitable to participate in the trial according to the laboratory test results or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration; | — |
Countries
China
Contacts
Public ContactHongzhou Lu
Shenzhen Third People's Hospital Medical
Outcome results
None listed