Tuberculosis and other diseases
Conditions
Interventions
T-R fast group:In the first cycle (4 days in total), 16 subjects took 1 pill of the test formulation orally in an empty stomach, after a washing period of at least 7 days, and in the second cycle (4 d
R-T fast group:In the first cycle (4 days in total), 16 subjects took 1 capsule of the reference formulation orally on an empty stomach, after a washing period of at least 7 days, and in the second cy
T-R fed group:In the first cycle (4 days in total), 16 subjects received 1 pill of the test preparation 30±0.5min after a high-fat meal. After at least 7 days of the washing period, 16 subjects receiv
R-T fed group:In the first cycle (4 days in total), 16 subjects received 1 pill of the reference formulation 30±0.5min after a high-fat meal, after a wash period of at least 7 days, and in the second
Sponsors
Hebei Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, voluntarily sign informed consent, be able to communicate well with the researcher, and understand and comply with the requirements of the study; 2) Healthy male and female subjects over 18 years of age (including 18 years of age) with an appropriate sex ratio; 3) Male weight >=50.0kg, female weight >=45.0kg; Body mass index (BMI) in the range of 19.0~26.0kg/m2 (including the critical value); 4) Vital signs measurement, reference value range: Systolic blood pressure 90~139mmHg (including boundary value), diastolic blood pressure 60~89mmHg (including boundary value), pulse 60~100 times/min (including boundary value), body temperature 36.0~37.0? (including boundary value), the results showed no abnormalities or abnormalities were not clinically significant, and the study doctors judged qualified patients; 5) The subjects (including male subjects) had no fertility plan from 1 month before screening to 6 months after the end of the test, and had no sperm donation or egg donation plan and voluntarily adopted effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1) Patients with past or current chronic or serious diseases of cardiovascular system, endocrine system, mental nervous system, digestive system, respiratory system, blood system, immune system, genitourinary system, eye, ear, nose and throat, skin, skeletal muscle (inquiry); 2) family history of psychosis (inquiry); 3) patients with a history of drug or food allergy or allergic constitution, and patients with a history of allergy to cycloserine or its excipents (talc) (inquiry); 4) patients with a history of dysphagia or any GI condition affecting drug absorption (inquiry); 5) lactose intolerance (diarrhea caused by consumption of milk and dairy products); 6) those who cannot tolerate venipuncture, have a history of dizzy with needle or blood, or have difficulty in venous blood collection; 7) having a history of drug abuse or using any drug within 6 months before screening; 8) patients with a history of surgery, trauma, or surgery within 6 months before screening or planned to undergo during the trial that may affect the safety or metabolism of the drug, and those who have undergone surgery that may affect the absorption, distribution, metabolism, or excretion of the drug; 9) blood donation, massive blood loss (>=400mL), transfusion or use of blood products within 3 months before screening; Or plan to donate blood or blood components during or within 3 months after the study; 10) subjects who consumed more than 14 units of alcohol per week in the 3 months before screening, or who could not abstain from alcohol during the study; 11) who smoked >5 cigarettes per day in the 3 months before screening or did not stop using any tobacco products during the study; 12) participants who participated in other drug clinical trials or used investigational devices within 3 months before screening and took investigational drugs or used investigational devices; Or those who are not personally enrolled in a clinical trial; 13) drinking tea, coffee and/or caffeinated beverages daily within 3 months before screening or unable to stop drinking during the trial; 14) use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes (e.g., inductors-barbiturates, carbamazepine, phenytoin, rifampicin; Inhibitors-ssri antidepressants, cimetidine, cyclosporine, diltiazem, macrolides, pyrrole antifungals, HIV protease inhibitors, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) and drugs affecting pharmacokinetics and subject safety (such as isoniazid, ethionamide); 15) vaccinated within 1 month before screening or plan to be vaccinated during the study; 16) who had taken any medicine (including Chinese herbal medicine) or health supplement within 14 days before screening; 17) eating within 48 hours before medication (including dragon fruit, mango, grapefruit, grapefruit, star fruit and its products) that may affect the absorption, distribution, metabolism, and excretion of the drug, or eating other foods that the researchers believe may affect the absorption, distribution, metabolism, and excretion of the drug; 18) had taken any alcoholic products within 48 hours before taking the drug, or had a breath alcohol test result >0mg/100mL; 19) laboratory tests (blood analysis, urinalysis + urine component analysis, blood biochemistry, and coagulation), physical examination, 12-lead electrocardiogram, and chest X-ray, if the investigators judged that the abnormal results were clinically significant; 20) clinically significant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cycloserine concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak concentration;AUC0-t, Area under the curve for the time from 0h before administration to the last detectable blood concentration;AUC0-8, Area under the curve from 0h before administration to extrapolation to infinity time;Tmax, Time to peak concentration;?z, Elimination rate constant;t1/2, Terminal terminal half-life was eliminated;AUC_%Extrap, Residual area percentage; | — |
Countries
China
Contacts
Public ContactYiting Hu
Hebei Provincial People's Hospital
Outcome results
None listed