Erectile dysfunction of the male penis
Conditions
Interventions
R-T group:Take the test preparation orally
T-R group:Take the reference drug
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily serve as a subject, and sign the informed consent form by oneself before the start of any research procedure; 2.Healthy male subjects aged 18 years or above; 3.Male weight >= 50.0kg; The body mass index (BMI) is within the range of 19.0 to 26.0kg/m ² (including the critical value); 4.The results of vital sign examination, physical examination, clinical laboratory tests (blood routine test, urine dry chemistry + urine sediment quantitative test, blood biochemical test, infection four-item test, coagulation four-item test), alcohol breath test, urine screening for drug abuse, and 12-lead electrocardiogram test, which are determined by the research doctor to be normal or abnormal and have no clinical significance; 5.From signing the informed consent form to within 3 months after the end of the trial, there were no plans for having children, and they voluntarily took effective contraceptive measures (Appendix 2) and had no plans for sperm donation; 6.Those who can communicate well with the researcher and understand and abide by all the requirements of this study;
Exclusion criteria
Exclusion criteria: 1.Allergic constitutions, such as those with a known history of allergy to certain substances, or those with a known history of previous allergy to vardenafil hydrochloride and related excipients (microcrystalline cellulose, cross-linked polyvinylidenone, colloidal silica, magnesium stearate, film coating premixes); 2.Those who developed acute diseases during the pre-study screening stage or before the study medication; 3.Those who have had or currently have the following diseases or chronic/severe medical histories and whose research doctors believe that they still have clinical significance at present, including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system, immune system, mental and nervous system, skeletal system, etc. Especially for those with gastrointestinal dysfunction, peptic ulcers and other gastrointestinal diseases that affect drug absorption, distribution, metabolism and excretion, or those with a surgical history within 3 months or planning to undergo surgery during the study period; 4.People with unstable angina pectoris; 5.Those who have a family history of degenerative eye diseases such as retinitis pigmentosa, or have experienced color weakness or vision loss, sudden deafness or hearing loss; 6.Patients with hypotension; 7.Those with penile anatomical malformations (such as angulation, cavernous fibrosis, Peyronie's disease) or inability to achieve penile erection (such as sickle cell disease, multiple myeloma and leukemia); 8.Those who have a history of stroke or myocardial infarction within six months; 9.Patients with severe liver injury or advanced kidney disease requiring dialysis; 10.Those with poor conditions for vascular puncture, who cannot tolerate venipuncture or have a history of fainting at the sight of needles and blood; 11.People with lactose intolerance, lactase deficiency or a history of glucose-galactose malabsorption (those who have experienced milk-induced diarrhea); 12.Those who have received a vaccine within 4 weeks before screening, or those who plan to receive any vaccine during the trial or within 1 week after the end of the study; 13.Those who have used any drugs (including prescription drugs, over-the-counter drugs, and Chinese herbal medicines), health supplements, and functional vitamins within 14 days prior to their first medication; 14.Those who have used any drugs that have interacted with vardenafil (such as nitrates, CYP 3A4 inhibitors (cimetidine, erythromycin, ketoconazole, itraconazole, clarithromycin, inddenavir, ritonavir), a -receptor blockers, lioxigumab) within 28 days before screening; 15.Those who have participated in or are currently participating in other clinical trials and have used investigational drugs or medical devices for intervention within the three months prior to screening; 16.Those who have received a blood transfusion or used blood products within 3 months prior to the first administration, or have a history of blood donation, or have lost more than 400mL of blood for other reasons, or plan to donate blood or blood components during the study period or within 1 week after the study ends; 17.Those who consumed an average of more than 14 units of alcohol per week within 3 months prior to the first administration (1 unit =360mL of beer or 45mL of 40% alcohol liquor or 150 ml of wine), or were unable to abdicate alcohol within 48 hours before the first administrat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?z;Tmax;t1/2;Vd/F;AUC_%Extrap;F;CL/F; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed