male erectile dysfunction
Conditions
Interventions
Test preparation and fasting group:tadalafil tablet administered once under fasting condition, 20 mg
Test preparation and fed group:tadalafil tablet administered once under fed condition, 20 mg
Reference preparation and fasting group:CIALIS administered once under fasting condition, 20mg
Reference preparation and fed group:CIALIS administered once under fed condition, 20mg
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Before the trial signed ICF, andfully understood the contents of the trial, the process and possible adverse reactions; 2) able to complete the study in accordance with the requirements of the trial Program; 3) Subjects (including male subjects) are willing to take no pregnancy plans within the next 6 months and voluntarily take effective contraceptive measures; 4) male subjects aged 18 to 65 years (including 18 and 65 years); 5) Male subjects weighing no less than 50 kg. BMI = body weight (kg) / height 2 (m2), BMI in the range of 18 to 28 (including the critical value); 6) health: no heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; 7) physical examination of normal or abnormal no clinical significance.
Exclusion criteria
Exclusion criteria: 1)3 months before the trial,daily smoking more than five pieces; 2) has a history of allergies to Tadalafil or its excipients; 3) Have a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = beer 285mL, or spirits 25 mL, or wine 100mL); 4) Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5) have difficulty of swallowing or any history of gastrointestinal disease that affects the absorption of drugs; 6) suffer from any disease that increases hemorrhagic risk such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 7) Take any drug that changes liver enzyme activity 28 days before taking the study drug; 8) Take any prescription drugs, non-prescription drugs, any vitamin products or herbs within 14 days prior to taking the study drug; 9) 2 weeks before the trial took a special diet (including dragon fruit, mango, grapefruit, and / or xanthine diet, etc.) or have strenuous exercise, or have other factors that can effect drug absorption, distribution, metabolism, excretion; 10) inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 11) There have been significant changes in diet or exercise habits recently; 12) took the research drug within three months before taking the study medication, or participated in the clinical trial of the drug (who participated in the fasting group ,can participate the fed group); 13) ECG abnormalities have clinical significance; 14) Clinical laboratory tests have clinically significant abnormalities, or other clinical findings showing clinically significant diseases (including but not limited to gastrointestinal, renal, liver, nerves, blood, endocrine, tumor, lung, immune, mental or heart Cerebrovascular disease); 15) hepatitis (including hepatitis B and hepatitis C) and AIDS screening positive; 16) acute disease before the study of the screening stage or before the study medication; 17) take Chocolate , any caffeine, or xanthine-containing food or drink 48 hours before taking the study drug; 18) taking any alcoholic products within 24 hours prior to taking the study; 19) Alcohol and drug screening positive or drug abuse history over the past five years or take drug 3 months before the trial; 20) investigators judged subjects who were not eligible to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed