None listed
Conditions
Interventions
Two groups:different drugs
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for inclusion: 1) aged >=18 years old, male or female; 2) the body weight of male subjects was >=50 kg, and that of female subjects was >=45 kg, with body mass index (BMI) between 19 and 26 kg/m2 (including critical value); 3) subjects voluntarily sign written informed consent; 4) subjects (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures from the screening period to 3 months after the end of the study (appendix 1) and have no sperm donation or egg donation plan.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: 1) any serious clinical diseases, including circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other diseases that may interfere with the results of the test; 2) allergic to drugs, food or other substances; 3) patients who underwent surgery within 4 weeks prior to the trial or plan to undergo surgery during the study period; 4) have taken any medicine (including Chinese herbal medicine) within 14 days before the test; 5) any drug that inhibits or induces liver metabolism (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) was used within 30 days prior to the trial;Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotizers, verapamil, fluoroquinolones, antihistamines, and bile acid chelators (e.g. 6) those who have taken any clinical trial drug or participated in any clinical trial of any drug within 3 months prior to the trial; 7) those who donated blood or suffered massive blood loss (>=200 mL), received blood transfusion or used blood products within 3 months before the test; 8) those who have special requirements for diet and cannot follow a uniform diet; 9) excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day; 10) smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the test; 11) heavy drinkers or regular drinkers in the 6 months prior to the trial, who drink more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); 12) drug abusers or those who have used soft drugs (e.g., marijuana) within 3 months before the trial or hard drugs (e.g., cocaine, benzcyclohexidine, etc.) within 1 year before the trial; 13) abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg;Heart rate 100 BPM) or physical examination, electrocardiogram, laboratory examination, abdominal b-ultrasound abnormality has clinical significance (subject to clinician's judgment); 14) tablet dysphagia; 15) those who cannot tolerate venipuncture, and/or have a history of needle and blood sickness; 16) female subjects are in lactation, pregnancy or positive blood pregnancy results during the screening period or during the test; 17) alcohol breath test results greater than 0 mg/100 mL; 18) urine drug screening (morphine, methyl-amphetamine, ketamine, dimethyl-dioxyamphetamine and tetrahydrocannabinic acid) results are positive; 19) major changes in diet or exercise habits in recent 3 months, such as weight loss, diet, exercise, fitness, etc.; Subjects may not be able to complete this study for other reasons or should not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentrations of aubcholic acid; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital of Central South University
Outcome results
None listed