pulmonary hypertension
Conditions
Interventions
1 group :The first cycle of fasting to take the test preparation
the second cycle of fasting reference preparation
the third cycle of fasting to take the test preparation
the fourth cycle of fasting reference preparation
2 group:The first cycle of fasting reference preparation
the third cycle of fasting reference preparation
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male subjects between 18 and 5 years of age(including 18 and 65); 2. At least 50kg for male , with a Body Mass Index (BMI) between 18-28kg/m2, inclusive(BMI = kg/m2); 3. Health status: heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; Physical examination showed that blood pressure, heart rate, electrocardiogram, respiratory system, liver, kidney function and blood normal are abnormal or no clinical significance; 4. Subjects (including male subjects) are willing to plan for the next 6 months without pregnancy and take voluntary contraceptive measures, specific contraceptive measures see appendix; 5. efore signing the informed consent form, and fully understand the experimental content, process and possible adverse reactions; 6. Can be completed in accordance with the requirements of the experimental program.
Exclusion criteria
Exclusion criteria: 1. Clinical laboratory tests have clinically significant abnormalities, or other clinically significant clinical manifestations of the following diseases (including, but not limited to, gastrointestinal, renal, hepatic, nerve, blood, endocrine, tumor, lung, immune, Cerebrovascular disease); 2. ECG abnormalities have clinical significance; 3. hepatitis (including hepatitis B and C) and HIV are positive; 4. Persons who have been screened for alcohol or drug positive or who have had drug abuse within the past five years or three months before the test; 5. More than 5 cigarettes smoked daily for 3 months prior to the trial; 6. Have allergies to Ambrisentan or accessories; 7. Have a history of drug and / or alcohol use (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 1 cup of wine); 8. Blood donation or massive blood loss (> 450 mL) within the first three months of administration of the study drug; 9. Any medication that changed liver enzyme activity was administered 28 days prior to the study drug; 10. Take any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days of taking the study drug; 11. took special diet 2 weeks before the test (including dragon fruit, mango, grapefruit, and / or xanthine diet, etc.) or strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion and other factors; 12. Take chocolate, any caffeine-containing, or xanthine-containing food or drink 48 hours before taking the study drug; 13. Take any alcoholic product within 24 hours of taking the study medication; 14. taking the study drug within three months of taking the study medication, or participating in a drug clinical trial; 15. have a history of gastrointestinal disease with dysphagia or any effect of drug absorption; 16. There have been major changes in diet or exercise habits recently. 17. Acute disease occurs during the pre-study screening phase or prior to study medication; 18. suffering from any increase in the risk of bleeding diseases, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 19. with the following inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;safety indicator; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed