UC(ulcerative colitis)
Conditions
Interventions
Trial group:After the subjects fasted for at least 10 hours overnight, the test drug (H021 tablets (T)) was administered in a single dose on an empty stomach. Aft
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.For males, the weight should be >= 50.0 kg; for females, it should be >= 45.0 kg. Additionally, the body mass index (BMI) should be within the range of 19.0 to 26.0 kg/m² (including 19.0 and 26.0. The BMI is calculated as weight (kg) divided by the square of height (m²), with the result 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 the absorption, distribution, metabolism and excretion of the drug, or any condition that may pose a risk to the subject, such as: i. Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal/rectal bleeding, persistent nausea or other clinically significant gastrointestinal abnormalities at the time of screening; ii. A history of major gastrointestinal surgery (such as: gastrectomy, gastroenterostomy, intestinal resection, gastric bypass, gastric division or gastric sac banding, cholecystectomy, but appendicitis surgery and rectal prolapse surgery are excluded); iii. Liver disease or a history or evidence of liver dysfunction at the time of screening (such as AST, ALT or total bilirubin > 1.5 times ULN); iv. Kidney disease or a history or evidence of renal dysfunction at the time of screening, manifested by clinically significant creatinine abnormalities or abnormal urine components (such as proteinuria, etc.). 5.Exclude those who have consumed excessive amounts (an average of more than 8 cups per day, 1 cup = 250 mL) of tea, coffee or caffeinated beverages within the previous 3 months; or those who consumed tea or any food or beverage containing caffeine (such as coffee, chocolate, etc.) within 48 hours before administration. 6.Those who smoked an average of more than 5 cigarettes per day over the past 3 months; or those who were unable to refrain from smoking throughout the entire trial period. 7.Select those who frequently consumed alcohol within the previous 3 months, that is, those who consumed more than 2 units of alcohol per day on average (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); or those who were unable to abstain from alcohol during the trial; or those whose alcohol breath test was positive. 8.Screen those who have donated blood or lost blood by more than 400 mL within the past 3 months (excluding physiological blood loss in women); or have received blood transfusion or used blood products; or are scheduled to donate blood during the medication period and within 3 months after discontinuation of the medication. 9.Those who have taken drugs within the past 3 months; or have a history of drug abuse or dependence within the past 12 months; or those whose urine drug test is positive at the time of screening. 10.Those who received the vaccine within the past 3 months; or those who plan to receive the vaccine within the next 3 months after the trial. 11.Select those who have participated in other clinical trials of drugs or devices within the past three months and have received treatment with the trial drugs or devices. 12.Exclude those who have consumed a large amount of beverages or foods rich i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative Bioavailability (based on AUC0-t);Pharmacokinetic Parameters (including AUC0-8, AUC0-t, Cmax, Tmax, Tlag, Kel, MRT, t1/2, CL/F, Vd/F, and AUC_%Extrap for H021 and metabolite M2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative Bioavailability (based on Cmax and AUC0-8); | — |
Countries
China
Contacts
Public ContactChen Guiling
SHULAN(QUZHOU)HOSPITAL
Outcome results
None listed