Drug-resistant TB
Conditions
Interventions
experimental group:Pirfazimine Tabletsin
control group:Pirfazimine Simulant
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) To sign the informed consent form before the study, and to fully understand the contents, process and possible adverse reactions of the study; 2) Be able to complete the research according to clinical trial Protocol; 3) Subjects (including partners) are willing to have no pregnancy plan for the next six months and voluntarily adopt effective contraceptive measures; 4) Male subjects aged 18 to 55 years (including 18 and 55 years old); 5) Male subjects weigh no less than 50kg .Body mass index (BMI) = weight (kg)/height 2 (m2), and BMI of 18~28kg/m2 (including critical ) 6) No clinical significance for normal or abnormal vital signs and physical examination
Exclusion criteria
Exclusion criteria: 1) Smoking more than 5 cigarettes per day in the 3 months before the test, or failing to comply with the prohibition of smoking during the test period; 2) Allergic constitution (multiple drug and food allergies); 3) Have a history of drug use and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL of liquor, or 100mL of wine); 4) Donate blood or mass loss of blood (> 450 mL) within three months before screening; 4) Donated blood within 1 month before screening, donated blood or lost a large amount of blood within 3 months before screening (> 450 mL); 5) Any drug that alters liver enzyme activity was taken 28 days before screening; 6) Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening; 7) Screening: had taken special diet (including pitaya, mango, grapefruit, etc.) or had strenuous exercise within 14 days before screening;Or other factors affecting the absorption, distribution, metabolism, and excretion of drugs; 8) Combined with the following CYP3A4, P-GP, or Bcrp inhibitors or inducers, such as itraconazole, ketoconazole, or dronedalon; 9) Recent significant changes in eating or exercise habits; 10) Have taken research drugs or participated in clinical trials of drugs within three months prior to screening; 11) Having difficulty swallowing or any gastrointestinal illness that affects drug absorption; 12) Any disease that increases the risk of hemorrhagic risk, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) 12-ECG abnormalities have clinical significance or male QTcB > 450ms; 14) Clinical laboratory examination were abnormal (such as lymphocyte count below the normal reference value lower limit), 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; 15) Abnormal chest radiographs, abdominal color ultrasound and retroperitoneal color ultrasound have clinical significance or color ultrasound shows mesenteric lymph nodes Swelling; 16) Screening for viral hepatitis (including hepatitis B and C), HIV antigen/antibody, and treponemal antibody (positive for treponemal antibody, determined by the researcher based on RPR results); 17) Acute disease or concomitant medication occurred from the screening stage to before the study; 18) Consume chocolate, any caffeinated or xanthine rich food or drink 24 hours before taking the study drug; 19) Has taken any alcoholic product within 24 hours prior to the use of the study drug; 20) Urine drug screening positive or having a history of substance abuse or drug use in the past five years; 21) Subjects who, in the opinion of the investigator, have other factors that are not appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactWang Chen
Outcome results
None listed