Erectile dysfunction
Conditions
Interventions
Elderly group:Aildenafil Citrate Tablets
Diabetes group:Aildenafil Citrate Tablets
Liver injury patient group:Aildenafil Citrate Tablets
Sponsors
Peking University first Hospital
Eligibility
Sex/Gender
Male
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: Elderly group (1)Male subject, age=65 years old. (2)The subject weighs not less than 50 kg and has a body mass index (BMI=square of body weight (kg)/height (m)) between 19-30 kg/m2 (including a threshold). (3)Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form. (4)Subjects are able to communicate well with the researcher and complete the study in accordance with the research regulations. Liver injury patient group (1)Male subject, 22 years old=age=70 years old (2)Patients with moderate liver function injury (based on the Child-Pugh diagnostic criteria, with a score of 7 to 9, and a grade of B) (3)Subjects weigh not less than 50 kg and have a body mass index (BMI=square of body weight (kg)/height (m)) between 19-30 kg/m2 (including threshold values) (4)The liver function status of the subject is stable, and there is little difference in clinical symptoms or laboratory indicators of liver injury in the past 2 weeks (subject to the judgment of the clinician). (5)Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form. (6)Subjects are able to communicate well with the researcher and complete the study in accordance with the research regulations. Diabetes group (1)Male subject, 22 years old =age=70 years old. (2)Type II diabetes (T2MD) patients have been diagnosed for at least 3 months. (3)Subjects weigh not less than 50 kg and have a body mass index (BMI=square of body weight (kg)/height (m)) between 19-30 kg/m2 (including threshold values). (4)Glycosylated hemoglobin (HbA1c) is between 6.5% and 11%. (5)Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form. (6)Subjects are able to communicate well with the researcher and complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: Elderly group (1) Major surgery was performed within 4 weeks before enrollment. (2) Persons who are known or suspected of being allergic or contraindicated to PDE5 inhibitors, aldenafil citrate tablets, or components thereof (including flavor correction agents). (3) Any drugs that inhibit or induce liver drug metabolism enzymes (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors - SSRI antidepressants, cimetidine, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) or any dosage form of nitrate or NO donor drugs have been used 30 days before enrollment. (4) The serological test results for syphilis, human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies were positive. (5) Any past or current medical history that may affect the safety of the test or the in vivo process of the drug, including but not limited to the nervous system, endocrine system, circulatory system, motor system, respiratory system, digestive system, urinary system Persons with reproductive system and other related diseases (such as viral hepatitis, liver cirrhosis, drug-induced liver injury, severe bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease history, acute renal failure, glomerulonephritis, interstitial nephritis, vascular dementia, Alzheimer's disease, psychosis, malignant tumors, etc.) or laboratory tests with significant abnormalities and clinical significance (such as alanine aminotransferase (ALT) /Aspartate transaminase (AST) > 3.0 × Upper limit of normal value (ULN); Serum creatinine (Cr) > 2.0 × ULN, etc.). (6) Have a history of cardiovascular disease, such as uncontrolled hypertension (systolic blood pressure = 170mmHg and/or diastolic blood pressure = 105mmHg without antihypertensive treatment; systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100mmHg with antihypertensive drug treatment), postural hypotension, severe arrhythmia, heart failure, Adams Stokes syndrome, unstable angina pectoris, history of myocardial infarction within 6 months, history of tachycardia/bradycardia Grade II to III atrioventricular block (excluding patients with pacemaker implantation) or QTcF interval = 450 ms (Fridericia correction formula). (7) Have a history of other allergies. (8) Those who have used soft drugs (such as ecstasy, KEN powder, and ephedrine) within 3 months before enrollment, or those who have used hard drugs (such as cocaine, heroin, and methamphetamine) within one year before enrollment, or those who have been screened positive for urinary drug abuse. (9) Those who have taken special diet (including pitaya, mango, grapefruit, etc.) or had severe exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before enrollment. (10) Chocolate, any caffeinated, or xanthine-containing foods or beverages were consumed 48 hours before enrollment. (11) Those who have special dietary requirements and cannot follow a unified diet. (12) Regular drinkers within the first 6 months of enrollment, i.e., those who drink more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine). (13) A history of smoking more than 5 cigarettes per day (or a significant amount of tobacco inhalation) or smoking less than 5 cigarettes per day during the first 3 months of enrollment, but unable to quit d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax;t1/2z;Vz/F;CLz/F;?z;MRT0-t;MRT0-8;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYiMin Cui
Peking University first Hospital
Outcome results
None listed