Rheumatoid arthritis
Conditions
Interventions
R-T group (fasting):In the first cycle, the subjects took the reference formulation (R) 4mg(1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 4mg(1 tablet) o
T-R group (fasting):In the first cycle, the subjects took the test formulation (T) 4mg (1 tablet) orally while fasting, and after 7 days, the subjects took the reference formulation (R) 4mg (1 tablet)
T-R group (after meals):In the first cycle, the subjects took the test formulation (T) 4mg (1 tablet) orally while fasting, and after 7 days, the subjects took the reference formulation (R) 4mg (1 tab
R-T group (after meals):In the first cycle, the subjects took the reference formulation (R) 4mg(1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 4mg(1 table
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as a subject, and Prior to the commencement of any study procedure, I shall sign an informed consent and guarantee to be taken by me throughout the study And test; 2. Male and female aged 18-45 years (including 18 and 45 years), with an appropriate sex ratio; 3. Male weight >=50.0kg, female weight >=45.0kg; Body mass index (BMI) was in the range of 19.0 to 26.0kg/m^2 (including critical values); 4. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine dry chemistry + urine sediment quantification, blood Biochemistry, Blood transfusion, blood coagulation function, blood pregnancy test (female), alcohol breath test, drug abuse Screening, COVID-19 screening, chest position, 12-lead electrocardiogram results showed no abnormality or abnormal clinical significance The Righteous One; 5. Have no pregnancy plan during the screening period and the next 3 months and voluntarily take effective contraception (Appendix 2) and do not donate Sperm and egg donation program; 6. Be able to communicate well with researchers and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any drug, food, etc., or history of specific allergic reactions (such as asthma, rubella, eczema) Sexual dermatitis) or severe allergic constitution, and the investigator judged clinical significance; 2. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption; 3. There is any blood circulation system, digestive system, urinary system, respiratory system, nervous system, immune system Any history of chronic or serious medical conditions, such as endocrine, mental, or metabolic disorders, that may interfere with the test Test results for any other disease, or previous or existing history of tuberculosis, or history of surgery within 3 months; 4. Patients with shingles within 3 months before screening; 5. Risk factors for deep vein thrombosis or pulmonary embolism, such as advanced age, obesity, deep vein thrombosis or pulmonary embolism Patients with history of obstruction or VTE risk score (based on Caprini model) > 2; 6. Poor vascular puncture conditions, or can not tolerate venous puncture, or have a history of fainting needle and fainting blood; 7. Those with a history of drug abuse in the 6 months prior to screening, or who have used drugs in the 3 months prior to screening, including for non-medical purposes Repeated, heavy use of various narcotic drugs and psychotropic substances, or urine addiction drugs morphine, methamphetamine Positive results for any one or more of the screening tests for tamine (methamphetamine), ketamine, dimethylene dioxyamphetamine (ecstasy), tetrahydrocannabinol (cannabis); 8. Participants who have participated in or are participating in other drug clinical trials within 3 months before screening; 9. Blood donation within 3 months prior to screening includes constituent blood or large blood loss (=400mL), receiving blood transfusion or using blood products This; Or intends to donate blood (including blood components) during or within 3 months after the end of the trial; 10. The woman is pregnant, breastfeeding, or the woman has unprotected sex or a blood pregnancy in the 14 days prior to the planned dosing Those with positive test results; 11. Use of any drug with potential interaction with baritinib within 1 month prior to administration (e.g., immunosuppressive drugs: Azathioprine, tacrolimus or cyclosporine; Transporters: Prosulfa, leflunomide or leflunomide, Burol Fen, diclofenac, digoxin, etc.; Cytochrome P450 enzymes: ketoconazole, fluconazole, simvastatin, ethinylestradiol Alcohol or levonorgestrel; Gastric pH regulator: omeprazole); 12. Have used any prescription drugs, over-the-counter drugs, Chinese herbs and vitamins within 14 days prior to administration; 13. Those who received vaccination within 3 months prior to screening, or who plan to receive vaccination during the trial; 14. Smoking more than 5 cigarettes per day in the 3 months prior to screening, or not stopping the use of any tobacco products during the trial This; 15. Average alcohol intake of more than 2 units per day in the 3 months prior to screening (1 unit =360mL beer, or 150mL Red wine, or 45mL distilled liquor), or those who tested positive for alcohol or did not agree to avoid drinking alcohol during the test; 16. Excessive consumption of strong tea, coffee, and/or caffeinated beverages per day (more than 8 cups, 1 cup) in the 3 months prior to screening =250mL); 17. Ingested strong tea, chocolate, coffee, or caffeine, alcohol, or xanthine (such as phoenix) wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8;AUC0-t;Cmax; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed