UC(ulcerative colitis)
Conditions
Interventions
After the meal - On an empty stomach group:Post-meal - fasting sequence group: In the first cycle, after a high-fat meal, take H021 tablets (T) 12.5 mg orally
after a 7-day washout period, in
Before meal - After meal group:In the first cycle, take H021 tablets orally on an empty stomach (T) at a dose of 12.5 mg
after a 7-day washout period, in the second cycle, take H02
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy adult subjects aged 18 to 55 years old (inclusive of 18 and 55 years old) (health refers to normal or abnormal results of medical history inquiry, physical examination and vital signs, chest X-ray (orthopside), laboratory tests, and 12-lead electrocardiogram, etc., with the exception that the results have no clinical significance as judged by the researchers), both male and female are included. 2.Body weight for men >= 50.0 kg, for women >= 45.0 kg, and body mass index (BMI): 19.0~26.0 kg/m^2 (including 19.0 and 26.0, BMI = weight (kg) / height^2 (m^2), rounded to one decimal place); 3.The subjects voluntarily signed the informed consent form. 4.The subjects have committed to having no plans for pregnancy, sperm donation or egg donation within 6 months from the screening stage until the last administration of the test drug, and to take appropriate contraceptive measures to prevent themselves or their partners from getting pregnant. 5.The subjects had a regular lifestyle and were able to maintain good communication with the researchers as well as comply with all the requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1.There are diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism and bones, as well as infectious diseases, diseases of important organs or medical histories, and the researchers believe that these will affect the safety of the subjects. 2.Those with a clinically significant history of food or drug allergies, or atopic allergic diseases (such as asthma, urticaria, eczema, etc.) or those who are known to be allergic to the ingredients and excipients of the investigational drug; 3.Those who had undergone surgery within the previous 3 months, or those who plan to undergo surgery during the study period; 4. Any disease or medical history that may significantly affect drug absorption, distribution, metabolism, and excretion, or any condition that may pose a risk to the subject, such as: (1) Presence of inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal/rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities at screening; (2) History of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric partition, gastric banding, cholecystectomy, except for appendectomy and rectal prolapse surgery); (3) Presence or history of liver disease or evidence of liver dysfunction at screening (e.g., AST, ALT, or total bilirubin >1.5 times ULN); (4) Presence or history of kidney disease or evidence of renal dysfunction at screening, manifested as clinically significant abnormal serum creatinine or urine composition abnormalities (e.g., proteinuria); 5. Consuming excessive tea, coffee, or caffeine-containing beverages within 3 months before screening (average of more than 8 cups per day, 1 cup = 250 mL); or consuming tea or any caffeine-containing food or beverage (e.g., coffee, chocolate) within 48 hours before dosing; 6. Smoking more than 5 cigarettes per day on average within 3 months before screening; or inability to refrain from smoking during the entire trial; 7. Frequent alcohol consumption within 3 months before screening, i.e., on average more than 2 units of alcohol per day (1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL wine); or inability to abstain from alcohol during the trial; or a positive breath alcohol test; 8. Blood donation or blood loss of =400 mL within 3 months before screening (excluding physiological blood loss in women); or receiving transfusions or blood products; or planning to donate blood during medication and within 3 months after discontinuation; 9. Use of illicit drugs within 3 months before screening; or history of drug abuse/dependence within 12 months; or a positive urine drug screen at screening; 10. Vaccination within 3 months before screening; or planning to receive vaccinations within 3 months after the trial ends; 11. Participation in other drug or device clinical trials within 3 months before screening and receiving investigational drugs or devices; 12. Consumption of large amounts of grapefruit-containing beverages or foods (e.g., grapefruit, grapefruit juice, grapefruit jam) within 14 days before screening; or consumption of any grapefruit-containing food or beverage within 48 hours before dosing; 13. Use of any prescription drugs, over-the-counter drugs, herbal medicine, or health supplements within 14 days before screening; 14. Virological tests, includ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics(AUC0-8?AUC0-t?Cmax); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical laboratory tests (blood routine, blood biochemistry, urine routine, infectious diseases); | — |
Countries
China
Contacts
Public ContactChen Guiling
SHULAN(QUZHOU)HOSPITAL
Outcome results
None listed