Primary biliary cholangitis
Conditions
Interventions
fasting group A:TRR
fasting group B:RTR
fasting group C:RRT
postprandial group A:TRR
postprandial group B:RTR
postprandial group C:RRT
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Aged >= 18 years, male and female; 2) The weight of the female volunteers should be >= 45.0kg and the weight of the male volunteers should be >= 50.0kg. The body mass index (BMI) should be between 19.0 and 26.0kg /m 2 (BMI = weight (kg)/height 2 (m 2), including the boundary value. 3) The volunteers did not have unprotected sex within 2 weeks before screening, and were barren during the experiment and within 3 months after the end of the experiment, planned to donate sperm/egg, and voluntarily took effective physical contraceptive measures; 4) Before the trial, the volunteers have thoroughly understood the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial, understood the procedures and methods of the study, were willing to strictly abide by the requirements of the whole clinical study, and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Those who are known to be allergic to the drug (obercholic acid), or who have a specific history of allergy (such as allergic asthma, urticaria, eczema, etc.), or who are allergic (such as allergy to two or more drugs, food or pollen); 2) Previous or present patients with any serious clinical disease or any other disease that can interfere with the test results, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities; 3) Those who have undergone major surgery within 4 weeks before the trial, or who plan to have surgery during the study period; 4) Those who have taken any medicine (including vitamin products and Chinese herbal medicine) within 14 days prior to the trial; 5) Any drugs that inhibit or induce drug metabolism in the liver (e.g. inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) were used within 1 month before the trial;Inhibitors - ssris antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 6) Those who have taken any clinical study drugs or participated in any clinical study of medical devices within 3 months prior to the trial, or plan to participate in other clinical trials during the study period; 7) Those who donate blood or lose blood >= 200 mL within 3 months before the test, receive blood transfusion or use blood products, or plan to donate blood ( >= 200 mL) within 1 month after the end of the test; 8) Smoking amount of > 5 per day in the first 3 months of the test; 9) Regular drinkers (more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with a 40% alcohol content or 150 mL wine) in the 3 months prior to the trial; 10) People who drank excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups per day on average, 1 cup =200 mL) during the first 3 months of the experiment; 11) People who cannot avoid eating any special food (such as grapefruit, chocolate, xanthine, tobacco, alcohol, caffeine, etc.) related to the study within 48 hours before the first use of the study drug and during the study period; 12) Unable to eat or having difficulty swallowing, or having special dietary requirements and unable to follow a uniform diet; 13) Drug abusers or those who have used soft drugs (e.g. marijuana) in the 3 months before the trial or hard drugs (e.g. cocaine, benzodiazepine, etc.) in the 1 year before the trial; 14) Abnormal vital signs during the screening period of this study (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg;Heart rate 100 BPM) or physical examination, 12-lead electrocardiogram, abdominal b-ultrasound (liver, bile and pancreas), thyroid function, clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, etc.) 15) Hepatitis b surface antigen, hepatitis c virus antibody, anti-human immunodeficiency virus antibody or anti-treponema pallidum antibody test has one or more positive; 16) Pregnant and/or lactating women, or women with positive blood pregnancy test; 17) > 0.0 mg/mL alcohol breath test; 18) Positive drug abuse screening; 19) Patients who have difficulty in venous blood collection or cannot tolerate venous puncture; 20) The volunteers were unable to complete the study due to personal reasons or the researchers consi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of permalidomide; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed