Erectile Dysfunction
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Gender: Chinese healthy male subjects; 2) Age: over 18 years old (including 18 years old); 3) Weight >= 50.0kg, and body mass index (BMI): 19.0~26.0kg/m2 (including boundary value, body mass index (BMI) = weight (kg)/height 2 (m2)); 4) Subjects must give informed consent of the study before the trail and sign a written informed consent form voluntarily ; 5) Subjects or their partners must be willing to use medically acceptable contraceptive methods within 6 months from the signing of the informed consent form to the end of the trial; 6) Subjects can communicate with the researcher well and complete the research in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1) Allergic constitution or a history of drug or food allergy, or known to be allergic to tadalafil; 2) The investigators believe that it has clinically meaningful liver, kidney, endocrine, cardiovascular, neurological, mental, gastrointestinal (such as peptic ulcer disease), lung, tumor, immunity, facial features, skin, reproduction, blood or metabolism disorders and other diseases or any other diseases, or have a history of these diseases, or have a history of major operations, or factors that will endanger the safety of the subject or affect the results of the study; 3) Physical examination, vital sign measurement, laboratory examinations (blood routine, urine routine, blood biochemistry, serum virology), 12-lead electrocardiogram, chest CT examination results, the investigator's judgment of abnormalities has clinical significance; 4) Alcohol breath test result is greater than 0.0mg/100mL or drug abuse and drug test positive; 5) There is a sperm donation plan or a partner has a pregnancy plan within 30 days before the administration to 6 months after the end of the study; 6) Have a history of drug abuse, or take any drugs (including Chinese herbal medicine) or functional vitamins habitually; 7) Any prescription drugs (especially any nitrate drugs), non-prescription drugs, health products or Chinese herbal medicines have been taken within 14 days before screening; 8) Excessive smoking (>=10 cigarettes/day) within 6 months before screening, or smoking within 48 hours before the first dose of the study or positive smoke test at screening, or smoking cannot be interrupted during the trial; 9) Past alcoholism [that is, men drink more than 28 standard units per week (1 standard unit contains 14g alcohol, such as 360mL beer or 45mL 40% alcoholic spirits or 150mL wine)], or often within 6 months before screening Drinking (drinking more than 14 standard units per week), or drinking within 48 hours before the first dose of the study, or drinking cannot be interrupted during the trial; 10) Excessive consumption of caffeinated beverages (more than 8 cups a day, 1 cup = 250mL) in the past for a long time, or any food or beverages containing caffeine (such as coffee, tea, cola, chocolate) within 48 hours before the first dose of the study Etc.), or the intake cannot be interrupted during the test; 11) Within 48 hours before the first dose of the study, take any grapefruit fruit or products containing grapefruit components, or not interrupt the intake during the test; 12) There are special requirements for diet and cannot comply with a unified diet; 13) Subjects with lactose or galactose intolerance, or subjects with malabsorption of glucose or galactose; 14) Have started a significantly abnormal diet (such as dieting, low sodium) within 4 weeks before screening; 15) Participated in other clinical trials within 3 months before screening; 16) Vaccination in 3 months before screening; 17) Blood donation or massive blood loss (>=200mL) within 3 months before screening; 18) Those who have difficulty in bleeding in veins, or cannot tolerate venipuncture, or have a history of fainting needles and bleeding; 19) The investigator considers any other factors that are not suitable for the subject to enter this trial.
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