Erectile dysfunction
Conditions
Interventions
Fasting Group A :T-R
Fasting Group B :R-T
After meal Group A :T-R
After meal Group B:R-T
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy Chinese male subjects; (2) Age at the time of signing the informed consent should be >= 18 and <=65; (3) Male subjects should not be lower than 50.0kg, body mass index [BMI = weight (kg) /height 2 (m2)] at 19.0 ~ 26.0kg / m2 In scope (including boundary values); (4) Subjects must understand informed consent and voluntarily sign informed consent; (5) Subjects are able to complete the study in accordance with the research plan; Those who do not meet one of the above conditions shall not be selected as subjects.
Exclusion criteria
Exclusion criteria: (1) Vital signs,physical examination, 12-lead electrocardiogram examination, laboratory test (blood routine, urine routine, blood biochemistry, coagulation function) during the screening period are judged to be abnormal clinical Meaning person by the researchers. (2) Those who Suffer from blood system (such as sickle cell anemia, multiple myeloma, leukemia), circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders ,Any metabolic history, penile anatomical abnormalities (such as penile deflection, cavernous fibrosis, Peyronie's disease), any history of serious clinical disease, or any other disease or physiological condition that can interfere with the test results; (3) Those who suffer from left ventricular outflow obstruction (such as aortic stenosis, idiopathic hypertrophic aortic stenosis),diseases with severe impairment of voluntary control of blood pressure, heart failure, coronary heart disease unstable angina pectoris ,myocardial infarction, shock or life-threatening arrhythmia?within 6 months before the study; (4) Those who have history of ophthalmology and ENT related diseases (such as pigmented retinitis, retinal edema, retinal vascular disease or bleeding, vitreous traction or peeling, perimacular edema, non-arterial ischemic neuropathy (NAION) history Person, hearing loss); (5) Those who have history of hypotension (including orthostatic hypotension) or experienced obvious orthostatic symptoms such as dizziness, light head, and dizziness from the supine position to the standing position; (6) Those who have clinically significant history of allergies, especially history of drug allergies, or those who are known to be allergic to sildenafil citrate or any of its components; (7) Hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody or HIV antibody test results are clinically significant; (8) Study the positive urine drug test (including morphine, methamphetamine, ketamine, dimethyl methylene oxyamphetamine, tetrahydrocannabinol); (9) Those with a history of drug abuse in the past 3 years (including the use of banned drugs, drugs and controlled drugs that are prohibited from medical use); (10) Those who have undergone surgery within 3 months before screening or plan to undergo surgery during the trial, and those who have undergone surgery that will affect drug absorption, distribution, metabolism and excretion. (11) Those who participated in any clinical trial and took drugs as subjects within 3 months before screening; (12) Blood donation or blood loss / plasma greater than 400mL within 3 months before screening; (13) Those who smoked excessively (average> 5 cigarettes / day) in the 3 months before screening, or those who could not stop using any tobacco products during the trial; (14) Alcoholics (men drink more than 28 standard units per week.1 standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with an alcohol content of 40% or 150mL wine) or frequent drinking within 6 months before screening (drinking more than 14 standard units per week), or those who cannot ban alcohol during the test, or those who have a positive breath test; (15) Those vaccinated within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed