Initial treatment of active tuberculosis in adults and children
Conditions
Interventions
Fasting R-T group:Subjects take one tablet of reference preparation in the first cycle and one tablet of test preparation in the second cycle on an empty stomach
Fasting T-R group:Subjects take one tablet of test preparation in the first cycle and one tablet of reference preparation in the second cycle on an empty stomach
Postprandial R-T group:After taking a high-fat meal, the subjects took one tablet of reference preparation in the first cycle and one tablet of test preparation in the second cycle
Postprandial T-R group:After taking a high-fat meal, the subjects took one tablet of test preparation in the first cycle and one tablet of reference preparation in the second cycle
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects over the age of 18 (inclusive); 2. The body mass index is in the range of 19.0~26.0 kg/m2 (including the critical value), and the weight of men is not less than 50 kg, and the weight of women is not less than 45 kg; 3. Screened within two weeks before the test, after vital sign evaluation, physical examination, blood routine, urine routine, blood biochemistry, coagulation function, infectious disease screening, pregnancy examination (women), 12-lead electrocardiogram and chest x-ray examination and other test results judged by the study doctor to be no abnormality or abnormal and clinically meaningless; 4. Those who have no abnormalities after drug abuse screening and alcohol breath test; 5. The subject did not have a family plan within 6 months after the end of the trial and voluntarily adopted effective contraceptive measures prescribed by the program, and the contraceptive measures are detailed in Appendix 4; 6. The subject fully understands the purpose, nature, method and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form; 7. Those who can complete the test according to the requirements of the program.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to any excipients in pyrazinamide tablets or those who are allergic (such as allergic to two or more drugs, foods and pollen); 2. Those who have difficulty in venous blood collection; 3. Those who have a history of drug abuse in the past five years or have used drugs in the 3 months prior to the trial; 4. Those who smoked more than 5 cigarettes per day or habitually used nicotine-containing products within 3 months before screening, drank more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits or 150 mL of wine with 40% alcohol content) or took alcohol-containing products 2 days before taking the drug; 5. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days prior to taking the study drug (eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors—ketoconazole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 6. Those who have used any prescription, over-the-counter or herbal medicine within 14 days prior to the start of the trial; 7. Those who have taken food or drinks (such as grapefruit, etc.) containing enzymes that can induce or inhibit liver metabolism within 1 week before the start of the trial; 8. Ingestion of any caffeine-producing or xanthine-rich food or beverage (e.g., coffee, tea, chocolate) containing or metabolizing between 48 h before taking the study drug and before completing the last pharmacokinetic blood sample collection; 9. Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, kidney (such as renal insufficiency), liver (such as hepatic insufficiency or bile stasis), gastrointestinal tract (such as dysphagia, gastrointestinal ulcers, gastrointestinal disorders), respiratory, metabolic, skeletal system diseases or other factors that may affect the absorption, distribution, metabolism and excretion of drugs; 10. Those with a history of gout or hyperuricemia; 11. History of arthralgia, myalgia or liver; 12. HIV-positive, hepatitis B virus surface antigen, hepatitis C virus antibody positive, syphilis pallidum antibody positive; 13. Female subjects with a positive pregnancy test or breastfeeding; 14. Those who have participated in other drug clinical trials within 3 months before the start of the trial; 15. Have a history of blood donation or blood loss of more than 400 mL in the 3 months before screening; 16. Those who have special dietary requirements and cannot comply with the unified dietary arrangement; 17. Any other circumstances that the investigator believes may affect the subject's provision of informed consent or compliance with the trial protocol, or the subject's participation in the trial may affect the test results or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;AUC_%Extrap;?z; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed