Primary biliary cholangitis
Conditions
Interventions
Fasting group 1:TIRT2R
Fasting group 2:RT1RT2
Fasting group 3:T2RT1R
Fasting group 4:RT2RT1
Sponsors
The Second Affiliated Hosptial of Xingtai Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have to give informed consent to the study and sign the written informed consent voluntarily before the trial; 2. Gender: Chinese healthy male or female, and the selected male and female subjects have appropriate gender ratio; 3. Aged 18-65 years old healthy subjects (including boundary value); 4. Male subjects with body weight >=50.0kg, female >=45.0kg, body mass index in the range of 19.0-26.0kg/m2 (including boundary value), body mass index (BMI) = body weight (kg) / height 2 (M2); 5. Subjects who can communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Any of the following conditions shall not be included in this test: 1. The subjects who were enrolled in other clinical trials and took corresponding test drugs or were participating in other clinical trials within 3 months before the trial; 2. Screening period physical examination, vital signs measurement, abdominal B-ultrasound (liver, gall, pancreas, spleen, kidney), laboratory item examination (including thyroid function, blood routine, urine routine, blood biochemistry, electrolyte, coagulation function, urine pregnancy (only for female subjects)), 12 lead ECG examination results the researcher judges the abnormal objects with clinical significance; admission blood pregnancy (only for female subjects) Sexual subjects) who are positive; 3. Patients with abnormal results of HBsAg, HCV antibody, Treponema pallidum antibody or human immunodeficiency virus antibody have clinical significance; 4. There are patients with cardiovascular, liver, kidney, endocrine, metabolism, digestive tract, blood system, respiratory system, infection, malignant tumor, nervous system and other medical history or existing above diseases judged as clinically significant by researchers; 5. Patients who had undergone major surgery or planned surgery during the study period within 6 months before screening, and those who had undergone surgery that would affect drug absorption, distribution, metabolism and excretion (excluding appendicitis and hernia repair surgery); 6. Before the test, the alcohol breath test results were more than 0.0mg/100ml or the weekly alcohol consumption was more than 14 standard units (1 standard unit contains 14g alcohol, such as 360ml beer or 45ml spirits with 40% alcohol or 150ml wine), as well as the subjects who could not accept alcohol prohibition during the whole test period; 7. The subjects who smoked more than 5 cigarettes per day in the first 3 months of the screening and who were not allowed to smoke during the whole period of the screening; 8. Those who are allergic to any component of obacholic acid tablet and its related compounds and excipients or to two or more drugs (or food); 9. The subjects who are positive in drug abuse and drug test before the test or who have drug abuse history within one year before the test (such as morphine, methamphetamine, ketamine, dimethyldioxygoamphetamine, tetrahydrocannabinolic acid, cocaine, etc.); 10. Subjects who donate blood or lose blood >=400ml within 3 months before the test, or who plan to donate blood or blood components during the study or within 3 months after the end of the study; 11. Pregnant or lactating women, or women who had unprotected sex within 14 days before the trial, and subjects (or their partners) were unwilling or unable to take one or more contraceptive measures between the trial period and 3 months after the end of the trial; or male subjects had sperm donor planners for women and female subjects had egg donor planners within 3 months after the end of the trial; 12. Those who had used long-acting estrogen or progesterone injection or implant within 6 months before the trial; 13. Any prescription drug, over-the-counter drug, Chinese herbal medicine or health care product used within 14 days before the test; 14. In the first 4 weeks of screening, any drug that interacts with OBC was used (such as choleric acid binding resin such as cholamine, coretipol or coravellin, warfarin, CYP1A2 substrate with narrow therapeutic index such as theophylline, CYP2C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hosptial of Xingtai Medical College
Outcome results
None listed