Erectile dysfunction
Conditions
Interventions
1:Food influence
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Age
22 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male aged 22 to 45 years; 2. BMI 19 to 26 (including 19 and 26), and more than 50 kg weight; 3. Past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening was determined healthy; 4. Subjects with fertility must agree to use reliable contraceptive methods during the study and at least 12 weeks after the last medication; 5. Understand the research program and voluntary signed informed consent form; 6. Subject is able to communicate with investigator well and comply with the protocol of the study
Exclusion criteria
Exclusion criteria: 1. Any clinically significant disease or surgery 4 weeks before the study; 2. Allergic to the product or its ingredients; 3. Any clinically significant disease including cardiovascular, endocrine, neurological , hematology ,immune, psychic or metabolic abnormalities disease; 4. Any history of color vision abnormalities, retinal pigmentitis, macular degeneration and other eye diseases or eye surgery history (such as cataract surgery); 5. Any history of gastrointestinal, hepatic or renal diseases that affect drug absorption or metabolism; 6. Any finding of Clinical laboratory evaluations are clinically significant abnormal, or having any clinically significant disease(routine bloodroutine urine blood biochemistryliver and kidney functions tests) 7. Any finding of physical examination, vital signs, electrocardiogram are clinically significant abnormal, or having any clinically significant disease(Systolic blood pressure less than 90 mmHg or more than 140mmHg and diastolic blood pressure less than 50 mmHg or more than 90mmHg; heart rate less than 60bpm or more than 100 bpm) 8. History of harmful use of alcohol six weeks before the study(Alcohol consumption of more than 14 standard drinks per week. A standard drink is defined as 360ml of beer or 45ml of distilled spirits or 150ml of wine) or refuse to quit drinking during the study; 9. Smokers (more than 1 cigarette per day) 3 months before the study or refuse to quit smoking during the study; 10. History of taking soft drugs (such as: marijuana) 3 months before the trial or taking hard drugs during the study (such as: cocaine, benzene cyclohexylidene, etc.) one year before the study or during the trial; 11. Overeating chocolate caffeinated coffee or tea, or any food or drinks containing caffeine(more than 8 cups) or refuse to quit drinking during the study; 12. Taking any drugs that inhibit or induce liver metabolism (eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI Antidepressants, cimetidine, diltiazem, macrolide, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) 30 days before the study; 13. Intake any drugs 14 days before the study; 14. Blood donation or blood loss = 400mL within 3 months before the study; 15. Participated in any drug clinical trial within 3 months before the study; 16. Any subjects who should not participate in this trial by the judgement of the invesitigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Youkenafil Hydrochloride;AUC0-t;AUC0-8;Cmax;CL/F;Tmax;t1/2;MRT;Laboratory outcome;The result of vital signs;Clinical symptoms; | — |
Countries
China
Contacts
Public ContactRui Wang, Beibei Liang
Chinese PLA General Hospital
Outcome results
None listed