PBC
Conditions
Interventions
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including male subjects) within the next 6 months without pregnancy plan and voluntary effective contraceptive measures, specific contraceptive measures see appendix; 4) healthy subjects aged 18 to 65 years (including 18 and 65 years); 5) male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 18 ~ 28kg / m2 (including the critical value); 6) health: heartless, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic abnormalities and other clinical history; 7) physical examination, vital signs normal or abnormal no clinical significance.
Exclusion criteria
Exclusion criteria: 1) 3 months more than 5 cigarettes per day or other tobacco products containing equal amounts of nicotine; 2) Allergenic or its accessories allergy, allergy (a variety of drugs and food allergy, except penicillin); 3) History of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 ml of wine); 4) Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5) Take any drug that changes liver enzyme activity 28 days before taking the study drug; 6) Take any prescription drugs, non-prescription drugs, any vitamin products or herbs (including contraceptives) within 14 days prior to taking the study drug; 7) 14 days before the test took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 8) There have been significant changes in diet or exercise habits recently; 9) took the research drug within three months before taking the study medication, or participated in the drug clinical trial; 10) dysphagia or any history of gastrointestinal disease that affects the absorption of drugs; 11) suffer from any disease that increases the risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 12) ECG abnormalities have clinical significance; 13) Laboratory tests suggest that there are clinically significant clinical findings, or other clinical examinations suggest that the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerves, blood, endocrine, tumor, lung, immune, mental or heart) Cerebrovascular disease); 14) Female subjects are in lactation or serum pregnancy outcomes during screening or during the trial; 15) hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening positive; 16) Acute disease before pre-study screening or before study; 17) Chocolate or any caffeine-containing food or drink was taken 48 hours before taking the study drug; 18) took any alcoholic products within 24 hours prior to taking the study; 19) Alcohol and drug screening positive persons who have used drugs in the past five years or have had a drug abuse history within 3 months before the trial; 20) have a history of gastrointestinal surgery or cholecystectomy; 21) Subjects who can not tolerate high-fat meal (2 boiled eggs 100g, 20g bacon, 1 butter toast 50g, 115g fried potato strips, 240ml whole milk) Test subjects).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed