Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
KF1:First cycle: ursonic cap
second cycle: ursodeoxycholic acid capsules
KF2:First cycle: ursodeoxycholic acid capsules
second cycle: ursonic cap
BF1:First cycle: ursonic cap
BF2:First cycle: ursodeoxycholic acid capsules
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age ranging 18~55 years old, both males and females with suitable ratio in the study; 2. Body weight of male >=50 kg, body weight of female >=45 kg and Body Mass Index (BMI) ranged within 19~26 kg/m2 including boundary values; 3. All subjects signed the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any clinically serious disease that has been or is currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities; (screening period); 2. Those who have a history of allergies to drugs (ursodeoxycholic acid or similar drugs), food or other substances; (screening period); 3. Those with a history of orthostatic hypotension; (screening period); 4. Patients with acute cholecystitis, cholangitis, biliary obstruction and frequent biliary colic disease or have undergone cholecystectomy (screening period); 5. Surgery within 4 weeks before the trial or scheduled for surgery during the study; (screening period); 6. Anyone who has used any drug within 14 days before the test (including Chinese herbal medicines and health care products) (screening period, check-in period); 7. Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg: Inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance, depressive drugs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines (screening period); 8. Any other clinical trial drugs or clinical trials of any other drug used within 3 months prior to the trial; (screening period, check-in period); 9. Those who have donated blood or accidentally lost more than 200 mL within 3 months before the test (screening period, check-in period); 10. Unprotected sexual behavior occurs during pregnancy and lactation or during the test period and within 3 months after the test and one or more contraceptive measures cannot be taken (screening period, check-in period); 11. Those who have special requirements for diet and cannot follow the unified diet; (screening period); 12. Drink excessive tea, coffee and beverages rich in caffeine or jaundice (8 cups or more, 1 cup = 250 mL) per day (screening period, check-in period); 13. Have eaten grapefruit juice, grape juice, cabbage vegetables, dragon fruit, mango, orange or food or drink prepared from it within 2 days before the test (screening period, check-in period); 14. Smokers or more than 5 cigarettes per day for the first 3 months of the trial; (screening period, check-in period); 15. Alcoholics or those who regularly drink alcohol within 6 months before the test, that is drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); check-in period) 16. Drug abusers or soft drugs (such as marijuana) used within 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test (screening period); 17. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; pulse 100 bpm; body temperature 36~37.2 degree C) are clinically significant (subject to the judgment of the research physician) (period, check-in period); 18. If the physical examination, electrocardiogram or laboratory examination is clinically significant (subject to the judgment of the research physician) (screening period); 19. Vasovagal syncope, poor vascular conditions or difficulty in puncture (screening period); 20. Patients with abnormal clinical significance of blood pregnancy (ß-HCG) examination (only for female subjects) (screening period, check-in period);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ursodeoxycholic acid; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Xiangya Boai Rehabilitation Hospital
Outcome results
None listed