Erectile dysfunction
Conditions
Interventions
clarithromycin tablets:On the first day, take 60 mg of Eddenafil Citrate tablets. Take clarithromycin tablets 500mg twice a day from the third to the fifth day. On the sixth day, take 500 mg of clarit
rifampicin capsule:On the first day, take 60 mg of Eddenafil Citrate tablets. Take rifampicin capsules 600 mg once a day from the third to the ninth day. On the tenth day, take both 600 mg of rifampic
cimetidine tablets:On the first day, take 60 mg of Eddenafil Citrate tablets. Take cimetidine tablets 400mg twice a day from the third to the fifth day. On the sixth day, take 400 mg of cimetidine tab
Multiple administration:On the first day, take 30mg once a day, once a day, and from the second to sixth days, take 30mg three times a day. On the seventh day, take 30mg once a day, once a day.
Nifedipine Group A:60 mg nifedipine controlled-release tablet was taken on the first day, 60 mg nifedipine controlled-release tablet was taken on the morning of the second day, 60 mg aidenafil citrate
Nifedipine Group B:60 mg nifedipine controlled-release tablet was taken on the first day, 60 mg nifedipine controlled-release tablet was taken on the m
Sponsors
Peking University first Hospital
Eligibility
Sex/Gender
All
Age
22 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Study on the interaction between clarithromycin and aildenafil citrate tablets (1) male subjects, 22 years old = age = 70 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 30kg/m2 (including the critical value). (3) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (4) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 2. Study on the interaction between rifampicin and aildenafil citrate tablets (1) male subjects, 22 years old = age = 45 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 30kg/m2 (including the critical value). (3) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (4) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 3.Study on the interaction between cimetidine aildenafil citrate tablets (1) male subjects, 22 years old = age = 45 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 30kg/m2 (including the critical value). (3) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (4) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 4. Study on the interaction between aildenafil citrate tablets and nifedipine controlled release tablets (1) male subjects, 22 years old = age = 60 years old. (2) have a history of mild to moderate essential hypertension. (3) take nifedipine controlled release tablets regularly (60mg/ / day) before entering the group (= 12 weeks). (4) the blood pressure level in the clinic remained stable during the screening period (blood pressure during the screening period < 140/90mmHg). (5) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 30kg/m2 (including the critical value). (6) the subjects must have informed consent to this study before the experiment and voluntarily sign a written informed consent form. (7) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 5. Study on the interaction between alcohol and aildenafel citrate tablets (1) male subjects, 22 years old = age = 45 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 24kg/m2 (including the critical value). (3) social drinkers. (4) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (5) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 6. Study on the interaction between dapoxetine hydrochloride tablets and aildenafil citrate
Exclusion criteria
Exclusion criteria: 1.Study on the interaction between clarithromycin, rifampicin or cimetidine and aildenafil citrate tablets (1)major surgical operations were performed within 4 weeks before entering the group. (2)people who are known or suspected to be allergic to or contraindicated to PDE5 inhibitors, aildenafil citrate tablets, clarithromycin, rifampicin, cimetidine or their components (including taste modifiers). (3)any drugs that inhibit or induce liver drug metabolism enzymes (such as inducers--barbital, carbamazepine, phenytoin, glucocorticoids, omeprazole, inhibitors--SSRI antidepressants, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) or any form of nitrate or NO donor drugs were used in the first 30 days. (4)the serological tests of syphilis, human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibodies were positive. (5)have other history of allergy. (6)those who used soft drugs (such as ecstasy, Ken powder, marijuana) within 3 months before joining the group, or used hard drugs (such as cocaine, heroin, methamphetamine) within one year before joining the group, or tested positive for urinary drug abuse. (7) those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise, or other factors affecting the absorption, distribution, metabolism and excretion of drugs within 2 weeks before entering the group. (8)Chocolate, any food or drink containing caffeine or xanthine was ingested 48 hours before entering the group. (9) those who have special requirements for diet and cannot abide by a uniform diet. (10)regular drinkers in the first 6 months, that is, drinking more than 14 units of alcohol per week (1 unit = 360mL beer or 45mL 40% spirits or 150mL wine). (11)those who smoked more than 5 cigarettes a day (or a considerable amount of tobacco inhalation) or smoked less than 5 cigarettes a day in the first 3 months, but could not quit smoking during hospitalization. (12)there is a history of blood donation or blood loss exceeding 400ml or any blood or blood products have been infused within 3 months before joining the group. (13)participated in any clinical study within 3 months before joining the group. (14)during the whole trial to 6 months after the subjects were out of the group, the subjects and their spouses were unwilling or unable to take the following contraceptive measures approved by doctors, such as condoms, IUDs, contraceptive rings, ligation, abstinence, etc. (15)subjects who were determined by the researchers to be unsuitable to participate in this clinical trial. (16)subjects engaged in driving and operating machines. Exclusion criteria applicable only to rifampicin: (1) any past or current medical history that may affect the safety of the trial or the process of the drug in vivo, including, but not limited to, nervous system, endocrine system, circulatory system, motor system, respiratory system, digestive system, urinary system, reproductive system and other related diseases. (2) during the screening period, after comprehensive physical examination, 12-lead ECG examination, vital sign examination (body temperature, blood pressure, respiratory rate, pulse), ophthalmology examination, positive position chest X-ray and laboratory examination (blood biochemistry, blood routine, urine routine, blood coagulation function) abnormalities have clinical significance (subject to the judgment of
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;pressure; | — |
Countries
China
Contacts
Public ContactYiMin Cui
Peking University first Hospital
Outcome results
None listed