Healthy Subjects
Conditions
Interventions
Fasting group 1:Ursodeoxycholic acid Suspension - Ursodeoxycholic acid Capsules
Fasting group 2:Ursodeoxycholic acid Capsules - Ursodeoxycholic acid Suspension
fed group 1:Ursodeoxycholic acid Suspension - Ursodeoxycholic acid Capsules
fed group 2:Ursodeoxycholic acid Capsules - Ursodeoxycholic acid Suspension
Sponsors
Hopeshine-Minsheng Hospital of Xinzheng
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have fully understood the contents, process and possible adverse reactions of the trial before the trial, and voluntarily sign a written informed consent form; 2. The subject has good communication with the investigator and is able to complete the trial according to the protocol; 3. Age: 18~55 years old (including boundary value); 4. Gender: Both men and women; 5. Weight: Male weight >= 50 kg, female weight >= 45 kg, body mass index (BMI) between 19~26 kg/m2 [BMI= weight (kg)/height2 (m2)], including boundary values.
Exclusion criteria
Exclusion criteria: 1. Have participated in any drug clinical trial within 3 months before screening; 2. History of acute cholecystitis or cholangitis, biliary obstruction, cholelithiasis, biliary colic, or cholecystectomy; 3. A person who is allergic to a drug, food, or a known history of allergy to ursodeoxycholic acid or its excipients; 4. The following diseases, including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, psychoneurologic system, five-organ department and other related diseases, are found clinically significant at screening; 5. Drugs that interact with ursodeoxycholic acid (e.g., bile acid chelating agents, such as cholestyramine and diazepam; aluminum antacids such as those containing aluminum hydroxide and/or montmorillonite; cyclosporine; drugs metabolized by CYP3A4, etc.); 6. Patients with any disease that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, and patients with active pathological bleeding or a history of intracranial bleeding; 7. Those who underwent major surgery within 6 months prior to screening, or who planned to undergo surgery during the study; 8. Use of soft drugs (e.g., cannabis) or drug abuse within three months prior to the trial screening positive; 9. Smoking more than 5 cigarettes per day on average during the 3 months prior to screening, or disagreeing to refrain from using any tobacco products throughout the trial; 10. Those who have a history of alcohol abuse or who regularly drink alcohol within the six months prior to screening, i.e. those who drink more than fourteen units of alcohol per week (360 mL of beer with an alcohol content of five percent or 45 mL of spirits with an alcohol content of forty percent or 150 mL of wine with an alcohol content of twelve percent) or who cannot stop alcohol intake or have a positive breath test during the study; 11. Blood donation or massive blood loss within three months prior to screening (200 mL or more, except for female physiological period); 12. Transfusion or use of any blood product within 3 months prior to screening; 13. Taking any drug (including prescription drug, over-the-counter drug, Chinese herbal medicine, etc.), health product or nutritional supplement within 2 weeks before taking the study drug; 14. Drinking excessive amounts of tea, coffee and/or caffeinated beverages (more than eight cups, one cup = 250 mL) per day for two weeks prior to screening or disagreeing to discontinue tea, coffee and/or caffeinated beverages or food during hospitalization; 15. Those who are accustomed to chewing areca nut, eating grapefruit or grapefruit products within 2 weeks before screening or do not agree to stop chewing areca nut, eating grapefruit or grapefruit products during hospitalization; 16. Significantly abnormal diets (e.g., high potassium, low fat, dieting, low sodium, etc.) have been started within 4 weeks prior to screening, or those who have special dietary requirements and cannot comply with unified diets (e.g., standard and high fat meals); 17. Lactose intolerance; 18. Has a history of dysphagia or any gastrointestinal disease affecting the absorption of drugs; 19. Patients with acute disease from screening period to study drug; 20. Vaccination within 1 month before screening or vaccination during the planned trial; 21. Difficult to collect blood or has a history of blood/needle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Safety measurement; | — |
Countries
China
Contacts
Public ContactJinxi Chen
Hopeshine-Minsheng Hospital of Xinzheng
Outcome results
None listed