Tuberculosis
Conditions
Interventions
Group 1:8 subjects in group 1 take a single dose of 200mg under fasted state on Day1 and 200mg after a high-fat meal on Day10
Group 2:8 subjects in group 2 take a single dose of 200mg after a high-fat meal on Day1 and 200mg under fasted state on Day10
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male or female subjects aged 18 – 45 (inclusive); 2) Weight = 50 kg, body mass index (BMI)=weight (kg)/(height) 2 (m2), BMI is 19.0 – 28.0 kg/m2 (including boundary value); 3) Those who have no birth plan during the trial and within 6 months after the completion of the trial and agree to use non hormonal contraceptive measures; 4) Those who understand the research procedures and methods, voluntarily participate in this trial, and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1) After inquiry and physical examination, it is found that the patient has cardiovascular, liver, kidney, digestive tract, respiratory, nervous, mental, immune, blood, endocrine and metabolic system diseases, or symptoms/signs of clinical significance; Or the subject reports the above disease history; 2) Vital signs (temperature, respiration, pulse rate, blood pressure), physical examination (height, weight, chest and abdomen examination, etc.) and laboratory examination (blood routine examination, urine routine examination, blood coagulation function, blood biochemistry, virological screening, etc.) are abnormal and of clinical significance; 12 lead ECG and chest X-ray examination were abnormal and of clinical significance; 3) Have a history of smoking (more than 5 cigarettes a day) and drinking (women consume more than 15 g of alcohol a day, men consume more than 25 g (15 g of alcohol is equivalent to 450 ml of beer, 150 ml of wine or 50 ml of low alcohol Baijiu, more than twice a week) and other bad habits, and have a history of drug abuse; 4) According to the judgment of the investigator, the subject may be allergic to the test drug or any component of the test drug; 5) Glutamic pyruvic transaminase and/or glutamic oxaloacetic transaminase>1.5 times the upper normal limit, and/or total bilirubin>1.5 times the upper normal limit; 6) Those who have undergone any surgery within 6 months before screening; 7) Estimated glomerular filtration rate eGFR 120 mL/min 1.73m2, the calculation formula is: eGFR=170 × (Scr)-1.234 × (Age) -0.179 × (0.79 female); 8) QTcF>450 msec in screening or baseline ECG (Formula of Fridericia method: QTcF=QT/(RR ^ 0.33)); 9) Those who participated in blood donation within 3 months before screening and the amount of blood donation was = 400 ml, or received blood transfusion; 10) Those who have participated in clinical trials of other drugs or medical devices within 3 months before screening; 11) Those who have used any prescription drugs (proton pump inhibitors, antacids, etc.), over-the-counter drugs, Chinese herbal medicine or food supplements that may affect the test drug within the first month of randomization; 12) Any acute disease with clinical significance determined by the researcher occurred within 1 month before screening; 13) Smoking, drinking, strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion 2 days before randomization; 14) Hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody positive; 15) Pregnant or lactating women; 16) Those who are not suitable for venous blood collection; 17) The investigator judges that the subject has diseases that affect the absorption, distribution, metabolism and excretion of drugs or can reduce compliance; Subjects may not be able to complete the study due to other reasons, or the investigators consider it inappropriate to participate in the study. 18) There were risk factors of torsade de pointes ventricular tachycardia or family history of short QT syndrome, long QT syndrome or sudden death; 19) A potent inhibitor or inducer known to be cytochrome P450 enzyme or any drug or substance known to prolong QT interval was used within 30 days before administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study execute time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics with foood effect;Safety and tolerance; | — |
Countries
China
Contacts
Public ContactHaiyan Li
Peking University Third Hospital
Outcome results
None listed