Primary biliary cholangitis
Conditions
Interventions
Group 1:Phase I: preparation 1
Phase ?: preparation 2
Phase ?: Reference preparation
Group 2:Phase I:Reference preparation
Phase II: Preparation 1
Phase?:Reference preparation
Phase ?: Preparation 2
Group3:Phase I: preparation 2
Phase ?: preparation 1
Group4:Phase I:Reference preparation
Phase II: Preparation 2
Phase ?: Preparation 1
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who have to give informed consent to the study before the trial and sign the written informed consent voluntarily; 2. Chinese healthy male or female subjects with appropriate gender ratio; 3. Aged 18-65 years old healthy subjects (including boundary value); 4. The body weight of male subjects >=50.0kg, female subjects >=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: 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. In the screening period, patients with results of physical examination, vital signs measurement, abdominal B-ultrasound (liver, gall, pancreas, spleen, kidney), laboratory items examination (including thyroid function, blood routine, urine routine, blood biochemistry, electrolyte, coagulation function, urine pregnancy (only for female subjects)), 12 lead ECG examination judged as clinical significance abnormality by the researchers; patients with positive results of blood pregnancy admitted (female subjects only) ; 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. The subjects whose alcohol breath test results are greater than 0.0mg/100ml before the test or who drink more than 14 standard units (1 standard unit contains 14g alcohol, such as 360ml beer or 45ml spirits with 40% alcohol or 150ml wine) every week within 3 months before the screening, as well as the subjects who can't be banned from alcohol during the whole test period after being selected; 8. Those who are allergic to any component of obacholic acid tablet and its related compounds and excipients, or those who are allergic 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 have unprotected sex within 14 days before the trial, and subjects (or their partners) who are unwilling or unable to take one or more contraceptive measures during the trial period and 3 months after the trial end, or male subjects who have a sperm supply plan for women and female subjects who have an egg donation plan within 3 months after the trial end; 12. Subjects who had used long-acting estrogen or progesterone injection or implant within 6 months before the trial; 13. Subjects who have used any prescription drug, over-the-counter drug, Chinese herbal medicine and health care product within 14 days before the test; 14. In the first 4 weeks, the subjects who had used any drugs (such as choleric acid binding resin such as cholestatic amine, coletipol or coravellan, warfarin, CYP1A2 substrate with narrow therapeutic index such as theophylline, CYP2C19 substrate such as omeprazole, tizanidine, bile salt efflux pump inhibitor such as cyclosporine, etc.) that had interaction with objec wer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed