Healthy Volunteer
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) 18-60 years old (including boundary value); 2) After inquiring about medical history, general physical examination, measuring vital signs and necessary laboratory tests (Different research parts have different requirements), it is determined that the subjects are healthy; 3) Those who understand the test procedure, voluntarily participate in the study, and are willing to comply with the requirements of the protocol, have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1). Have a history of needle/blood sickness; 2).Currently suffering from diseases or symptoms requiring drug control; those who have previously suffered from diseases of cardiovascular system, respiratory system, digestive system, urogenital system, blood system, central nervous system, mental disease, autoimmune and endocrine metabolic abnormalities that have clinical significance determined by researchers; 3). Any drug (including OTC, traditional Chinese medicine, etc.) has been used within 2 weeks before the test, or the time after taking the drug is less than 10 half-lives; 4). Those who have used any drugs that inhibit or induce liver CYP3A4 drug metabolism enzymes within 30 days before the test (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 5). Those who had taken food that affected the metabolism of CYP3A4 enzyme, such as broccoli, cabbage, grapefruit, grapefruit juice, carambola, etc within 14 days before the test; 6). Those who has other conditions judged by the researcher to be unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine tertiary bile acids;Area Under Time-Concentration Curve; | — |
Countries
China
Contacts
Public ContactJia Miao
Clinical Trials Center,West China Hospital of Sichuan University
Outcome results
None listed