Erectile Dysfunction, Pulmonary Hypertension
Conditions
Interventions
5mg dose group:Randomly receive 5 mg of test drug or placebo according to a ratio of 5:1, and take it orally on an empty stomach in the morning
10mg dose group:Randomly receive 10 mg of test drug or placebo according to a ratio of 5:1, and take it orally on an empty stomach in the morning
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. The weight of male volunteers is >= 50.0 kg, the weight of female volunteers is >=45.0 kg, and the body mass index (BMI) is between 19 and 26 kg/m^2, including the critical value; 3. Signed a written informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. Those who have suffered or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other disease that could interfere with the test results; 2. Electrocardiogram at screening QTcF > 450ms (male), QTcF > 470ms (female) (Fridericia's formula: QTcF = QT/(RR)1/3); 3. Those with eGFR 20 mmHg or the diastolic blood pressure drops >10 mmHg, refer to "Chinese Guidelines for the Management of Hypertension in the Elderly 2019"); 5. Have a history of allergies to drugs, food or other substances; 6. Those who have undergone surgery within 4 weeks before the trial, or who plan to undergo surgery during the study; 7. Those who have taken any drugs or health products (including Chinese herbal medicine) within 14 days before the test; 8. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the test (such as: inducersbarbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitorsSSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 9. Those who participated in any clinical trial and took any clinical trial drug within 3 months before the trial; 10. Those who donated blood or lost a large amount of blood ( >= 200 mL, excluding menstrual blood loss in women), received blood transfusion or used blood products within 3 months before enrollment; 11. Those who cannot tolerate venipuncture and/or have a history of fainting blood or needles; 12. Pregnant or lactating patients, as well as patients who cannot use one or more non-drug contraceptives during the trial; 13. Those who cannot take contraceptive measures within 6 months after administration; 14. Those who have special requirements for diet and cannot follow a unified diet or have difficulty swallowing; 15. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 16. Those who have ingested or planned to ingest grapefruit or grapefruit-related citrus fruits (such as lime, grapefruit), star fruit, papaya, pomegranate or above fruit products within 14 days before taking the study drug for the first time; 17. Smokers or those who smoked more than 5 cigarettes per day in the first 3 months of the trial or those who could not stop using any tobacco products during the trial; 18. Alcoholics or frequent drinkers within 6 months prior to the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine) or those who cannot stop using any alcoholic products during the trial; 19. Drug abusers or those who have used soft drugs (such as marijuana) 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 20. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Vital signs;Laboratory examination;ECG examination;Any spontaneously reported and all directly observed adverse events; | — |
Countries
China
Contacts
Public ContactYang Guoping, Pei Qi
Outcome results
None listed