erectile dysfunction
Conditions
Interventions
Fasting:1 tablet of IP taken per period, total 2 periods
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Subjects willing to provide written informed consent and able to understand the protocol requirements, study procedures and potential adverse event; 2) Subjects willing to adhere to the protocol requirements; 3) Subjects(partners included) willing to have no pregnancy plan within the next 6 months and follow effective birth control methods listed in the appendix; 4) Male subjects aged between 18 to 65 years (both inclusive); 5) Subjects' weight within normal range according to normal values for Body Mass Index (18 to 28kg/m2 (both inclusive)) with minimum of 50 kg; 6) Health conditions: there is no history of significant cardiovascular,hepatic,renal,gastrointestinal, neurological,respiratory or psychiatric disease or disorder. 7)Subjects having normal or no clinical significant physical examination and vital signs.
Exclusion criteria
Exclusion criteria: 1) Daily smoking more than 5 cigarettes during past 3 months; 2) Hypersensitivity to Tadalafil or any of its excipient; 3) History or presence of drug abuse or alcoholism(taking 14 units of alcohol per week: 1 unit is equal to 285 mL of beer,or 25 mL of spirits, or 100 ml of wine); 4) Volunteer who have donated blood or have blood loss within 3 months prior to screening(more than 450mL ); 5) Difficulty in swallowing solids like tablets/capsules or history of gastrointestinal diseases affecting drug absorption; 6) History or presence of significant easy bleeding,such as haemorrhoids,acute gastritis,gastric and duodenum ulcers; 7) Use of any medication affecting the activity of hepatic enzyme during last 28 days prior to screening ; 8) Use of any prescribed medication,OTC medication,vitamins and herbal remedies during last 14 days prior to screening; 9) Consumption of any special diet(including dragon fruits ,mangos,grapefruit ,etc) or presence of strenuous exercise or other factors affecting drug absorption, distribution, metabolism, excretion; 10) Consumption of inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 11) Subjects who have great changes on diet and exercise recently. 12) Consumption of investigational products, or participating in a clinical trial during last 3 months prior to dosing; 13) Subjects who have special requirements on diet(subject who couldn't accept the standard diet including 2 eggs 100g,20g bacon,1 piece of bread 70g,115g chips,240mg milk ); 14) Presence of significant ECG; 15) Presence of significant laboratory examination or diseases (including but not limited to the gastrointestinal, renal,hepatic,neurological, hematic, endocrine, tumor, respiratory, immune, psychiatric or cardiovascular disease); 16) Positive screening test for any one or more: Hepatitis B, Hepatitis C,HIV,RPR; 17) Presence of illness or concomitant medication from screening to dosing; 18) Consumption of chocolate,caffeine/xanthine-containing products within 48 hours prior to dosing; 19) Consumption of alcoholic products within 48 hours prior to dosing; 20) Positive screening test for urine drug or history for drug abuse and consumption of narcotics past 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;Vd/F;CL/F; | — |
Countries
China
Contacts
Public ContactGuoCheng Zhang
The First Hospital of Jilin University
Outcome results
None listed