Atopicdcrmatis
Conditions
Interventions
RT Group:In the postprandial test, healthy subjects should start having a standard meal 30 minutes (+/-1 minute) before taking the medicine, control the eating speed, and finish the meal before taking
TR Group:In the postprandial test, healthy subjects started to have a standard meal 30 minutes (+/-1 minute) before taking the medicine, controlled the eating speed, and finished the meal before takin
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Before the trial, sign the informed consent form and fully understand the content, process and possible adverse reactions of the trial. 2. Be capable of completing the research in accordance with the requirements of the test plan; 3. The subjects (including their partners) had no pregnancy plans from 2 weeks before self-administration of the drug to 6 months after the last administration of the study drug and voluntarily adopted effective contraceptive measures. The specific contraceptive measures are detailed in Appendix 5. 4. Healthy male and female subjects aged 18 and above (including 18 years old); Male subjects should weigh no less than 50 kilograms and female subjects no less than 45 kilograms. Body mass Index (BMI) = weight (kg)/height (m^2). The BMI should be within the range of 19.0 to 26.0kg/m^2 (including the critical value). 6. Normal or abnormal physical examination and vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1.Select those who have used any clinical trial drugs within the past three months or have participated in any clinical trials of drugs or medical devices. 2.Have a history of allergies to the components of the test drug or its analogues, or have an allergic constitution (allergic to two or more drugs and foods); 3.Select those who smoked more than 5 cigarettes per day in the previous 3 months, or those who were unable to stop using any tobacco products during the trial period; 4.Exclude those who have undergone major surgery within the past 3 months or who plan to undergo surgery within 3 months after the end of the trial; 5.Select individuals who have consumed alcohol frequently within the past 6 months, that is, those who have consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or those who cannot guarantee to give up alcohol during the trial period; 6.Exclude individuals who have donated blood within the past 3 months or who have experienced significant blood loss (more than 450 mL) (excluding menstrual blood loss for women), those who have received blood transfusions or used blood products, and those who plan to donate blood during the trial period. 7.Exclude those who have received treatment with JAK inhibitors, biological immunomodulators, or other immunosuppressants within the past 3 months; 8.Have taken any prescription drugs, over-the-counter drugs, any vitamin products or herbal remedies within the past 14 days?; 9.Subjects who have taken any drugs that alter liver enzyme activity within the past 1 month, or who are concurrently using any inhibitors or inducers of CYP3A4, CYP2D6, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone, etc., will be excluded from the study. 10.Exclude those who received vaccinations or attenuated live vaccines within the previous 1 month, or those who plan to receive vaccinations during the trial period; 11.Exclude those who have taken special diets (such as dragon fruit, mango, grapefruit, etc.) within the past two weeks, or have engaged in intense exercise, or have any other factors that may affect the absorption, distribution, metabolism, or excretion of the drug; 12.Those who have difficulty in swallowing and are unable to take the medicine in its entirety; 13.Have special dietary requirements and cannot follow a uniform diet or cannot tolerate standard meals; 14.Those with chronic or recurrent infections, or with a history of severe or opportunistic infections, or who have experienced systemic infections within the previous 6 months (including herpes zoster, disseminated herpes simplex virus infections, etc.), or who have resided or traveled in areas with a tuberculosis epidemic or fungal disease epidemic; 15.Those with a history of tuberculosis, a family history of tumors, or severe liver dysfunction; 16.Abnormalities in electrocardiogram have clinical significance. 17.Female subjects were in the lactation period or were experiencing a positive serum pregnancy test result during the screening period or the trial process; 18.Clinical laboratory tests (blood biochemistry, blood routine, urine routine, coagulation function tests), and abnormal findings in chest X-ray examinations have clinical significance. 19.Have a history of chronic or severe diseases in the cardiovascular system, digestive system, urinary reproductive system, respiratory system, blood system, endocrine system, immune syst
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed