A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol

Inclusion Criteria: Participants who can understand and are willing to strictly follow the clinical trial protocol to complete the trial and sign the informed consent; Male participants aged 18~45 years (including the cut-off value); Weight≥50.0kg; Body mass index (BMI) in the range of 19.0~26.0kg/m^2 (including the critical value); Good health, no history of respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and other serious diseases or chronic diseases; Do not plan to have children during the trial, and agree to use reliable contraception during the trial and for 3 months after the last study drug administration, and do not plan to donate sperm. Exclusion Criteria: Allergic: allergic to drugs, food, pollen, alcohol, etc., known to be allergic to experimental drugs or other PDE5 inhibitors and excipients; Patients with difficulty swallowing tablets/capsules; Or according to 0.5g/kg body weight intake of alcohol (that is, 70kg body weight participants drink 35g pure alcohol, equivalent to 50 degrees of liquor about 70g) may be intoxicated; Or have special dietary requirements and cannot accept the standard diet provided by the research center; Patients who have a history of needle fainting and blood fainting, can not tolerate venous puncture blood collection and/or have difficulty in blood collection; Patients with abnormal color vision judged by researchers to have clinical significance; Or have known to have retinitis pigmentosa, macular degeneration, nonarteriotic anterior ischemic optic neuropathy (NAION) eye disease; Or have known fundus medical history that other investigators have deemed unsuitable for inclusion; People who have experienced sudden hearing loss or hearing loss in the past; Past or existing postural hypotension/syncope; Clinically significant vital signs (reference value range: 90 mmHg≤systolic blood pressure (sitting) <140 mmHg, 60 mmHg≤diastolic blood pressure (sitting)<90 mmHg, 55 times/min≤pulse rate (resting)≤100 times/min, 35.5℃≤body temperature (axillary temperature)≤37.2℃; Participant to the judgment of the study physician); Or physical examination, 12-lead electrocardiogram, laboratory test results, the investigator judged that the abnormality is clinically significant; Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum specific antibody, human immunodeficiency virus antibody any abnormal clinical significance; Those who have used soft drugs (such as cannabis) within 3 months before screening or hard drugs (such as cocaine, amphetamines, Phencyclidine, etc.) within 1 year before screening; Or have a history of drug abuse; Or positive urine drug screening before randomization; Positive breath test for alcohol; Smokers who have smoked more than 5 cigarettes per day in the 3 months before screening or could not stop using any tobacco products during the test; Participants in any clinical trial within 3 months prior to screening; Those who have participated in blood donation and total blood donation or total blood loss≥400mL within 3 months before screening, or participated in blood donation and total blood donation≥200mL or total blood loss≥200mL within 1 month; Or receiving blood transfusion; Or plan to donate blood within 1 month after the end of this trial; Those who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the trial; Those who have received vaccination within 30 days prior to screening, or who plan to receive vaccination during the trial; Use of any CYP3A4/5 inhibitors or inducers (e.g., inhibitors-itraconazole, fluconazole, clarithromycin, ritonavir, cimetidine, diltiazem, etc.) within 28 days prior to randomization; Inducers-rifampicin, phenobarbital, carbamazepine); Those who have taken any prescription drugs, non-prescription drugs, health products, vitamins, or Chinese herbs within 14 days before randomization; Those who have eaten grapefruit, pomelo, dragon fruit, mango and other fruits or related products that affect metabolic enzymes within 7 days before randomization; People who ingested beverages or foods rich in caffeine or xanthine (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours before randomization; Patients who developed acute disease from the screening stage to before randomization; Participants judged by the investigator to be unsuitable for this clinical trial.