Atopic dermatitis, rheumatoid arthritis, psoriatic arthritis
Conditions
Interventions
Postprandial - Group 1(Group T-R):Oral administration of one tablet of test preparation after a high-fat, high-calorie meal in the first cycle,one tablet of the reference preparation after a high-fat,
Postprandial - Group 2(Group R-T):Oral administration of one tablet of reference preparation after a high-fat, high-calorie meal in the first cycle,one tablet of the test preparation after a high-fat,
Sponsors
Shulan (Hang Zhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment; 2) Capable of completing research according to the requirements of the experimental plan; 3) The subjects (including partners) have no pregnancy plans and voluntarily adopt effective contraceptive measures (specific contraceptive measures are listed in Appendix 5) from 2 weeks before self medication to 6 months after the last study drug administration, and there is no sperm donation plan for males and no egg donation plan for females; 4) Male and female participants aged 18 to 65 years old (including 18 and 65 years old); 5) The weight of male subjects shall not be less than 50.0 kilograms, and the weight of female subjects shall not be less than 45.0 kilograms. Body mass index (BMI)=weight (kg)/height 2 (m2), with a BMI ranging from 18.0 to 28.0 kg/m2 (including critical values); 6) Vital sign examination, physical examination, clinical laboratory examination (blood biochemistry, blood routine, urine routine), infectious disease screening, T-SPOT examination, serum pregnancy test (limited to women of childbearing age), 12 lead electrocardiogram examination normal or judged abnormal by researchers without clinical significance.
Exclusion criteria
Exclusion criteria: 1) History of allergies to the experimental drug, allergic constitution (allergies to two or more drugs and food); 2) Smoking more than 5 cigarettes per day in the first 3 months of screening, or unable to guarantee quitting smoking during the trial period; 3) Screening for frequent drinkers within the first 6 months, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol strong liquor or 150 mL of wine), or those who cannot guarantee to give up drinking during the trial period; 4) Blood donation or significant blood loss (>450mL) within the first 3 months of screening; 5) Screening individuals who have undergone surgery within the previous 3 months or plan to undergo surgery during the study period, and whose surgery may affect drug absorption, distribution, metabolism, and excretion; 6) Have a history of tuberculosis or tumor; 7) Individuals with chronic or recurrent infections, or those with a history of severe or opportunistic infections, or those who have experienced systemic infections in the 6 months prior to screening; 8) History of swallowing difficulties or any gastrointestinal diseases that affect drug absorption; 9) Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers; 10) Screening for other clinically significant diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, psychiatric, or cardiovascular diseases) identified within the previous 12 months; 11) Screening individuals who have consumed excessive amounts of tea, coffee, and/or caffeinated beverages daily within the past 3 months (8 or more cups, 1 cup=250mL); 12) 28 days prior to screening, taking any drugs that alter liver enzyme activity, or combining inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or dronedarone; 13) Have taken any prescription drugs, over-the-counter drugs, vitamin products, or herbs within the 14 days prior to screening; 14) Individuals who have consumed a special diet (including dragon fruit, mango, grapefruit, etc.) or engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within the past 2 weeks prior to screening; 15) There have been significant changes in dietary or exercise habits recently; 16) Have taken the investigational drug or participated in drug clinical trials within the past 3 months prior to screening; 17) Screening individuals who have received vaccines or live attenuated vaccines within the previous month, or who plan to receive vaccines during the trial period; 18) Those who have special dietary requirements and cannot accept a uniform diet; 19) Individuals who cannot tolerate venipuncture or have a history of needle or blood dizziness; 20) Female subjects who are breastfeeding or have positive serum pregnancy results during the screening period or trial process; 21) Acute illness or concomitant medication occurs from the screening stage to the study medication; 22) Consuming chocolate, any caffeinated or xanthine rich food or beverage within 24 hours prior to taking the study drug; 23) Have taken any alcoholic products or tested positive for alcohol breath test within 24 hours before taking the study medication; 24) Individuals with positive urine drug screening results or a history of drug abuse within the past five year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;Eliminating terminal half-life;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactChen Guilin
Shulan (Hang Zhou) Hospital
Outcome results
None listed