rheumatoid arthritis
Conditions
Interventions
Sequence 1:Dosing group A (T19, fasting) - Dosing group B (T19, high-fat, high-calorie) - Dosing group C (reference formulation, fasting)
Sequence 2:Dosing group C (reference formulation, fasting)-Dosing group A (T19, fasting) - Dosing group B (T19, high-fat, high-calorie)
Sequence 3:Dosing group B (T19, high-fat, high-calorie) - Dosing group C (reference formulation, fasting)-Dosing group A (T19, fasting)
Sequence 4:Dosing group C (reference formulation, fasting)- Dosing group B (T19, high-fat, high-calorie) -Dosing group A (T19, fasting)
Sequence 5:Dosing group A (T19, fasting) - Dosing group C (reference formulation, fasting)- Dosing group B (T19, high-fat, high-calorie)
Sequence 6:osing group B (T19, high-fat, high-calorie)-Dosing group A (T19, fasting) - Dosing group C (reference formulation, fasting)- D
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects sign the informed consent before the study, and fully understand the content, process and possible adverse effects of the study; participate voluntarily and be able to complete the study in accordance with the requirements of the protocol; 2. Healthy male and female volunteers who have signed the informed consent and are 18 years of age or older (including 18 years of age); 3. Male subjects weighing no less than 50.0 kg and female subjects weighing no less than 45.0 kg, with a body mass index (BMI) within the range of 19.0-28.0 kg/m2 [BMI = weight (kg)/height2 (m2)] (including the threshold value); 4. Subjects (including male subjects) are willing to have no birth control plans and voluntarily use effective non-pharmacological contraception (see Appendix) within 6 months from screening to the last dose of study drug, and do not plan to donate sperm or eggs.
Exclusion criteria
Exclusion criteria: 1. Those who have occurred or are experiencing diseases with abnormal clinical manifestations that need to be excluded prior to screening, including but not limited to diseases of the nervous/psychiatric system, respiratory system, cardiovascular and cerebral vascular system, digestive system (any history of gastrointestinal disorders affecting the absorption of medications), blood and lymphatic system, liver and renal function, endocrine system, and immune system; 2. Those with a history of tuberculosis or a family history of tumors; 3. Those with chronic or recurrent infections, or a history of serious or opportunistic infections, or those who have had a systemic infection (including viral infections such as herpes zoster, disseminated herpes simplex, etc.) in the 6 months prior to screening, or those who have had any signs or symptoms related to an active infection (e.g., fever, cough) or localized infections in the 7 days prior to screening 4. Those with any disease that increases the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers; 5. Blood lymphocytes with an absolute value of less than 0.5 x 10^9/L, blood neutrophils with an absolute value of less than 1.5 x 10^9/L or hemoglobin of less than 90 g/L; 6. 12-lead electrocardiogram, vital signs examination, physical examination and clinical laboratory tests (routine blood, urine, blood biochemistry, coagulation function), serology, follicle stimulating hormone (female only), pregnancy test (female only), chest X-ray (orthopantomogram), blood test for alcohol, and screening for drug abuse, with results showing abnormalities of clinical significance; 7. Blood creatinine clearance = 80mL/min (creatinine clearance = (140 - age) x body weight (kg) / (0.818 x creatinine value CREA (µmol/L)), multiply by 0.85 if female); 8. Those who have undergone surgery within 1 month prior to screening or plan to undergo surgery during the study period, and those who have undergone surgery that would affect drug absorption, distribution, metabolism, or excretion; 9. Persons with atopic allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or allergies (e.g., allergies to two or more medications, foods such as milk, and pollen), or known allergies to tofacitibine or other components of the drug; 10. Those who have used any prescription drugs, over-the-counter drugs, herbs and vitamins within 2 weeks prior to screening; 11. Those who have consumed an average of greater than 14 units of alcohol per week (1 unit of alcohol ˜ 360mL of beer or 45mL of spirits with 40% alcohol by volume or 150mL of wine) in the 3 months prior to screening, or who are unable to abstain from alcohol during the trial; 12. Those who have smoked an average of greater than 5 cigarettes per day in the 3 months prior to screening, or who are unable to abstain from the use of any tobacco-based products during the trial period; 13. Donation of blood, including component blood, or significant blood loss (=400mL) within 3 months prior to screening; 14. Those who have a history of substance abuse within 6 months prior to screening; 15. Those who have used drugs within 3 months prior to screening; 16. Any drug that inhibits or induces hepatic metabolism of drugs (e.g., inducers - rifampicin, phenytoin, carbamazepine, omeprazole, phenobarbital, dexamethasone, neomycin, etc.; depressants - SSRI-type antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK outcome (AUC0-t, AUC0-inf, Cmax.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety outcome (adverse events, vital signs monitoring, 12-lead electrocardiogram, physical examination, clinical laboratory tests (routine blood, urine, blood biochemistry, coagulation)); | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed