Rheumatoid arthritis
Conditions
Interventions
Fasting administration.-postprandial administration:Dose in the fasting state in the first cycle and after a high-fat meal in the second cycle
Postprandial administration - Fasting administration group:Dose after consuming a high-fat meal in the first cycle and in a fasted state in the second cycle
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The age is 18-45 years old (including the critical value), and the single sex ratio is appropriate; 2. Male weight>=50kg, female weight>=45kg; Body mass index (BMI) between 19 and 26 kg/m2 (including critical values); 3. The subjects are fully aware of this study, voluntarily participate, and have signed a written informed consent form; 4. The subjects are able to communicate well with the researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Allergy: Known to be allergic to the investigational drug or its formulation components, or similar active drugs; Individuals with known drug allergies, food allergies, special dietary requirements, history of allergic diseases, or allergic constitution; 2. Those who currently have obvious or clinically significant diseases/abnormalities (including but not limited to neurological, cardiovascular, blood and lymphatic systems, immune system, kidney, liver, gastrointestinal, respiratory, metabolic, and skeletal system diseases, as well as a history of malignant tumors) in clinical practice, or those who have a history of these diseases and have been judged by the researcher to be potentially affecting their safety or research results; 3. Lactose intolerant individuals (those who have experienced diarrhea due to drinking milk); 4. Frequent history of infection within the past year (with>=3 episodes), or a history of infection within 3 months before administration, such as recurrent oral herpes, genital herpes, herpes zoster, and other recurrent viral infections; Or those who have previously or latent infections with Mycobacterium tuberculosis( ? Interferon release test (T-SPOT) positive); 5. physical examination or abnormal vital signs (temperature, pulse, blood pressure) with clinical significance; 6. Those with abnormal laboratory test results and clinical significance during screening; 7. Those with positive hepatitis B surface antigen, hepatitis C antibody, or syphilis spirochete specific antibody at screening, and those with non negative AIDS virus (HIV) antibody; 8. Those with clinically significant abnormal electrocardiogram or chest X-ray results during screening (all chest X-ray results within 3 months of our hospital are valid); 9. Those who have difficulty collecting blood or are unable to tolerate venous puncture, or have a history of needle and blood fainting; 10. Screening for individuals who have undergone any surgery within the first 3 months, or who plan to undergo surgery during the trial period (including cosmetic surgery, dental surgery, and oral surgery); 11. Those who have donated or lost blood (>=400mL) within the first 3 months of screening, or have received blood or blood component transfusions, or have planned to donate blood during the trial period; 12. Those who have participated in clinical trials of any drug or medical device within the first three months of screening and received the medication (including the placebo group); 13. Inoculate live or attenuated vaccines within 3 months before the first administration, or inactivate vaccines within 1 month, or plan to receive live, attenuated, or inactivated vaccines during the trial period; 14. Those who take any prescription drugs, Chinese herbal medicines, over-the-counter drugs, and vitamins within 4 weeks before administration; 15. Individuals with a history of drug abuse or positive urine drug screening (morphine, tetrahydrocannabinoid acid, methamphetamine, dimethylenedioxyamphetamine, ketamine); 16. Screening for individuals who smoke more than 5 cigarettes or an equivalent amount of tobacco per day within the first 3 months, or who are unable to quit smoking during the trial period; 17. Individuals who have consumed more than 14 units of alcohol per week (1 unit of alcohol ˜ 360mL of beer or 45mL of 40% alcohol or 150mL of wine) within the first 3 months of screening, or who have tested positive for alcohol breath test on the day before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;physical examination;vital signs;laboratory test;Chest X-ray (orthopantomograph) examination;ECG monitoring;adverse event; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangy
Outcome results
None listed