Pulmonary hypertension, PAH
Conditions
Interventions
25mg:25mg or placebo, BID, 7 days
50mg:50mg or placebo, BID, 7 days
100mg:100mg or placebo, BID, 7 days
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1 Healthy male and female subjects aged 18–45 years (inclusive); 2 Body weight >= 50.0 kg for males and >= 45.0 kg for females, with body mass index (BMI) ranging 19.0–26.0 kg/m^2 [BMI=weight(kg)/height^2 (m^2)] (inclusive); 3 Subjects (including male participants and their female partners) must agree to use effective non-pharmacologic contraception (see Appendix) from 2 weeks prior to screening until 6 months after the last dose, with no plans for pregnancy, sperm donation, or egg donation during this period; 4 Subjects must provide written informed consent before screening, fully understand the study content, procedures, and potential adverse reactions, and be able to comply with the protocol requirements to complete the study.
Exclusion criteria
Exclusion criteria: 1. Presence or history of clinically significant diseases (including but not limited to circulatory, endocrine, neurological, digestive, respiratory, hematologic/lymphatic, urinary, or immune system disorders) or any condition that may interfere with trial results (e.g., movement disorders, seizure history, depression, angle-closure glaucoma, etc.) prior to screening. 2. History of chronic/active gastrointestinal diseases (e.g., perforation, fistula, esophageal disorders, gastritis, peptic ulcer, enteritis, GERD, pancreatitis, active bleeding) or gastrointestinal surgery; or >10% body weight fluctuation within 3 months before screening. 3. Gastrointestinal symptoms (diarrhea, constipation, nausea, vomiting, irregular bowel movements, or alternating diarrhea/constipation) within 7 days prior to screening, deemed ineligible by investigators. 4. History of undiagnosed skin lesions or melanoma. 5. History of hypotension. 6. History of severe coronary artery disease, unstable angina, myocardial infarction within 6 months, decompensated heart failure, severe arrhythmia, congenital/acquired valvular defects unrelated to pulmonary hypertension; or cerebrovascular events (e.g., TIA, stroke) within 3 months. 7. History of drug/food/substance allergies or hypersensitivity. 8. Surgery within 3 months before screening, planned surgery during the study, or prior surgeries affecting drug ADME (absorption, distribution, metabolism, excretion). 9. Use of any prescription/non-prescription drugs, herbal products, supplements, or vitamins within 14 days before screening. 10. Use of hepatic enzyme inhibitors/inducers (e.g., inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives, verapamil, fluoroquinolones, antihistamines) or strong CYP2C8 inhibitors (e.g., gemfibrozil) within 30 days before screening. 11. Participation in other drug trials within 3 months before screening or planned participation during the study. 12. Blood donation (including components) or blood loss >= 400 mL within 3 months before screening. 13. Intolerance to venipuncture or history of needle/phobia. 14. Use of oral contraceptives within 30 days or long-acting estrogen/progestin injections/implants within 6 months before screening. 15. Lactating/pregnant women or females with unprotected sex within 14 days before screening. 16. Inability to comply with standardized diets or history of dysphagia. 17. Excessive daily consumption of tea/coffee/caffeinated beverages (>8 cups/day, 1 cup˜250 mL) within 3 months before screening. 18. Smoking >5 cigarettes/day within 3 months before screening or inability to abstain from tobacco products during the trial. 19. Alcohol intake >14 units/week (1 unit˜360 mL beer/45 mL 40% liquor/150 mL wine) within 3 months before screening or inability to abstain during the trial. 20. History of drug abuse within 6 months before screening. 21. Use of illicit drugs within 3 months before screening. 22. Clinically significant abnormalities in vital signs, physical examination, ECG, echocardiography, or lab tests (CBC, urinalysis, blood biochemistry, coagulation, immunology, pregnancy test [females], pituitary/thyroid function, stool analysis) per investigator judgment. 23. Positive blood alcohol test within 24 hours before dosing. 24. Positive drug abuse screening within 24 hours before dosing. 25. Consumption of food
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of any adverse events that occurred during the clinical study in the subject; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) ; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed