Erectile dysfunction and pulmonary hypertension
Conditions
Interventions
experimental group A:DDCI-01 capsules were given under fasting conditions in the first cycle and DDCI-01 capsules were given under postprandial conditions in the second cycle.
experimental group B:DDCI-01 capsule was given under postprandial conditions in the first cycle and DDCI-01 capsule was given under fasting conditions in the second cycle.
Sponsors
Center for Clinical Trials and Research, 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, both male and female; 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 ~ 26 kg/m2, including critical value; 3.Volunteers voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have previously or are currently suffering from any serious clinical diseases such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry, and metabolic abnormalities, may interfere with the test results Any other diseases; 2. ECG examination during screening QTcF>450ms (male), QTcF>470ms (female) (Fridericias formula: QTcF= QT/(RR)1/3); 3. For those with eGFR 20 mmHg or the diastolic blood pressure drops > 10 mmHg, refer to the "Guidelines for the Management of Hypertension in the Elderly 2019"); 5. History of allergies to drugs, food or other substances; 6. Those who have received surgery within 4 weeks before the test, or plan to perform surgery during the study period; 7. Those who have taken any medicines or health products (including Chinese herbal medicine) within 14 days before the test; 8. Any drugs that inhibit or induce liver metabolism of drugs (such as inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) have been used within 30 days before the test; inhibitors-SSRI anti-drugs Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 9. Participate in any clinical trial and take any clinical trial drugs within 3 months before the trial; 10. Those who donated blood or lost a lot of blood (>=200 mL, excluding blood loss during menstrual period), 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 and needles; 12. Pregnant or lactating women, and volunteers who cannot use one or more non-drug contraceptive measures during the trial period; 13. Those who cannot take contraceptive measures within 6 months after administration; 14. Those who have special requirements for diet, cannot follow a uniform diet or have difficulty swallowing; 15. People who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 16. Those who have consumed or plan to consume grapefruit or grapefruit-related citrus fruits (such as lime, grapefruit), carambola, papaya, pomegranate or more 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 3 months before the test or who could not stop using any tobacco products during the test; 18. Alcoholics or those who drink regularly in the 6 months before the test, that is, drink more than 14 units of alcohol per week (1 unit = 360 mL beer); Alcohol or 45 mL of 40% alcoholic spirits or 150 mL of wine) or those who cannot stop using any alcoholic products during the test; 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 100 bpm) or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Trials and Research, the Third Xiangya Hospital, Central South University
Outcome results
None listed