Erectile dysfunction
Conditions
Interventions
A (fasting):Test preparation - Reference preparation
B (fasting):Reference preparation-Test preparation
C (postprandial):Test preparation - Reference preparation
D (postprandial):Reference preparation-Test preparation
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Gender: Healthy male subjects; 2) Age: 18 years old or above (including 18 years old); 3) Weight: Male subjects should not be less than 50 kg, and their body mass index (BMI) should be within the range of 19.0-26.0 kg/m2 (including boundary values); 4) Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form; 5) The subjects (including their partners) have no plans to have children and voluntarily adopt appropriate and effective contraceptive measures (see Appendix 1 for specific contraceptive measures) from the time of signing the informed consent agreement until 6 months after the end of the trial, and have no plans to donate sperm; 6) The subjects are able to communicate well with the researchers and complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1) Screening period physical examination, vital signs, clinical laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, serum virology examination, etc.), 12 lead electrocardiogram, and results judged by the researcher as abnormal and clinically significant; 2) Individuals who have special dietary requirements or are unable to adhere to a standardized diet (such as intolerance to high-fat and high calorie foods) or have difficulty swallowing; 3) Allergic constitution refers to individuals who have a known history of allergies to two or more substances, especially those who are known to be allergic to tadalafil or any ingredients in this product or its excipients; 4) Subjects with lactose or glucose galactose intolerance (such as those who have experienced milk diarrhea); 5) Individuals with a history of cardiovascular disease (including myocardial infarction, unstable angina, ventricular arrhythmia, shock, transient ischemic attacks), or those who have previously or currently suffer from any clinically serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolic abnormalities, and have been determined by researchers to have clinical significance or interfere with test results; 6) Individuals with a history of hereditary retinal degeneration, pigmentary retinitis, non arterial anterior ischemic optic neuropathy (NAION), and sudden hearing loss; 7) Have a history of alcoholism or drink more than 14 units of alcohol every week within 6 months of the screening period (1 unit=360 mL beer or 45 mL Baijiu or 150 mL wine with 40% alcohol); Those who cannot abstain from alcohol or consume alcoholic products within 48 hours before the first administration and during the trial period, or those whose alcohol breath test results are greater than 0.0 mg/100mL; 8) Individuals who consume excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=200 mL) daily, or who have consumed or cannot stop consuming any beverages or foods containing caffeine components, such as coffee, tea, cola, chocolate, etc., within 48 hours before the first administration and during the trial period; 9) Individuals with a history of smoking, or with an average daily smoking volume of = 5 cigarettes in the 3 months prior to the trial, or who cannot stop using any tobacco products, including any nicotine containing smoking cessation products, within 48 hours before the first administration and during the trial period; 10) Within 48 hours before the first dose of the trial and during the trial period, if ingested or unable to stop consuming foods that may affect drug metabolism (such as grapefruit, grapefruit, mango, grape juice, etc. or containing the above ingredients); 11) Individuals who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health supplements, and functional vitamins within 14 days prior to their first medication; 12) Within 30 days prior to the first use of the investigational drug, any medication that may interact with tadalafil was used (such as nitrate drugs - nitroglycerin tablets, isosorbide dinitrate tablets; alpha receptor blockers - phentolamine, tolazolin, prazosin); Antihypertensive drugs - amiodarone, angiotensin II receptor blockers, benzothiazepine, enalapril, metoprolol; Antacids - magnesium hydroxide, aluminum hydroxide; H2 antag
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax;AUC0-8; | — |
Countries
China
Contacts
Public ContactGou Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed