Drug-resistant TB
Conditions
Interventions
6 groups:po.
Sponsors
Xiyuan Hospital CACMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 50 years (including 18 and 50 years old); 2. Male subjects weigh no less than 50kg and female subjects weigh no less than 45 kg.Body mass index (BMI) = weight (kg)/height 2 (m2), and BMI of 19~26kg/m2 (including critical value); 3. Healthy subjects are defined as those with mild abnormalities that are normal or not clinically significant in medical history, physical examination, ecg, and laboratory examination, or who are considered qualified by the investigator; 4. Subject must have informed consent prior to the study and voluntarily signed a written informed consent. The subject is able to communicate well with the investigator and complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. The researcher and the relevant personnel of the research center and their family members; 2. Have participated in 3 or more drug clinical trials as a subject in the past one year; Or participate in any clinical trial as a subject within 3 months prior to the trial; 3. Allergic to any food or drug; 4. Clinical laboratory examination were abnormal or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit or heart cerebrovascular disease); 5. Ultrasonic Bshowed mesenteric lymph node enlargement; 6. Have special requirements for food and are unwilling or unable to complete the dietary control plan during the study period; 7. Abnormal ecg has clinical significance or male QTCb>450ms or female QTCb> 470ms; 8. Pregnancy and lactation women, or blood HCG positive test, or pregnancy plans in the next 6 months and unwilling to take effective contraceptive measures; 9. Those with a history of needle sickness were judged to have clinical significance by the researchers; 10. A history of drug absorption or urine screening positive; 11. Viral hepatitis (including hepatitis b and c), HIV antibody, and treponema pallidum; 12. More than 450mL of blood was donated within 1 month before screening or 3 months before screening; 13. Have a history of alcohol abuse (21 units of alcohol per week: 1 unit = 360 mL beer, or 45 mL of liquor, or 150mL of wine) or the subjects were not willing to stop drinking at the end of the study 24 hours before the start of the study, or alcohol breath test positive at the time of admission; 14. Smoking more than 5 cigarettes a day during the first 3 months of the trial, or failing to comply with the smoking ban during the trial; 15. anyone who has used any drug within two weeks prior to taking the test drug; 16. according to the researcher's judgment, it is not suitable for the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;plasma concentration; | — |
Countries
China
Contacts
Public ContactLan Pei
Peking Union Second Phaemaceutical Factory
Outcome results
None listed