Erectile dysfunction
Conditions
Interventions
Fasting Group A:Test Product - Reference Product
Fasting Group B:Reference Product - Test Product
Fed Group A:Test Product - Reference Product
Fed Group B:Reference Product - Test Product
Sponsors
Phase I Clinical Trial Laboratory of Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects must understand informed consent and voluntarily sign informed consent; 2. Subjects are able to complete the study in accordance with the study protocol; 3. Subjects (including mate) have no plans to become pregnant from 2 weeks before administration to 6 months after the last administration and voluntarily take effective contraceptive measures; 4. Healthy Chinese male subjects; Aged 18-50 years at the time of signing the informed consent; 5. Male subjects should not be lower than 50.0 kg, body mass index [BMI = weight (kg) /height 2 (m2)] at 19.0 ~ 26.0 kg/m2 (including margin values); 6. Physical examination, normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1. Those who smoked more than 5 cigarettes per day in the last 3 months before the study; 2. Have a history of allergies to the test drugs, allergic constitution (multiple drugs and food allergies); 3. A history of alcoholism within 3 months before the study (drinking 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine); 4. Blood donation or massive blood loss (>450mL) within 3 months before screening; 5. Those with positive urine drug screen or a history of drug abuse within the past five years; 6. History of dysphagia or any gastrointestinal disease that affects drug absorption; 7. Those who have a history of hypotension (including orthostatic hypotension) or have obvious postural symptoms such as dizziness, light-headedness, and dizziness from supine to standing; 8. History of ophthalmology and otolaryngology-related diseases (such as retinitis pigmentosa, retinal edema, retinal vascular disease or hemorrhage, vitreous traction or dissection, permacular edema, history of non-arterial anterior ischemic neuropathy (NAION) hearing loss, hearing loss); 9. Clinical laboratory examinations have clinically significant abnormalities, or patients with blood system (such as sickle cell anemia, multiple myeloma, leukemia), circulatory system, digestive system, urinary system, and respiratory system within 12 months before screening, nervous system, immune system, endocrine system, malignant tumor, mental abnormality and metabolic abnormality, penile anatomical malformation (such as penile deviation, cavernous fibrosis, Peyronie's disease) and any history of serious clinical disease or any medical history that can interfere with the test results Other diseases or physical conditions; 10. Taking the following inhibitors or inducers of CYP3A4, CYP2C9, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone, etc. within 28 days before screening; 11. Have taken any prescription drug, over-the-counter drug, any vitamin product or herbal remedies within 14 days prior to screening; 12. Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) within 14 days before screening, or have had vigorous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion; 13. Significant changes in diet or exercise habits within 1 month before screening; 14. Have taken sildenafil within three months before taking the study drug, or participated in a clinical trial of the drug; 15. Subjects who cannot tolerate a standard meal (two hard-boiled eggs, a piece of buttered bacon toast, a box of fried potato chips, a glass of whole milk); 16. Abnormal ECG has clinical significance; 17. Persons with positive tests for hepatitis B surface antigen, hepatitis C virus core antigen, hepatitis C virus antibody, Treponema pallidum specific antibody, and human immunodeficiency virus antibody; 18. Acute disease or concomitant medication occurred from the screening stage to the study medication; 19. Consumed chocolate, any caffeinated or xanthine-rich food or drink 48 hours before taking the study drug; 20. Have taken any alcohol-containing products or a positive alcohol breath test within 48 hours before taking the study drug; 21. The investigator considers that the subject is not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum blood concentration;Blood concentration from point zero to the last measurable concentration time point t;Blood concentration from zero to infinity; | — |
Countries
China
Contacts
Public ContactChen Guiling
Outcome results
None listed