Healthy subjects
Conditions
Interventions
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male or female subjects between the ages of 18 and 65 years old (including the threshold value); 2) Body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including the threshold value), with a body weight of not less than 50.0 kg for males and not less than 45.0 kg for females; 3) Subjects (including male subjects) are using effective contraception (Appendix 2) within 2 weeks prior to the screening date and within 3 months after the last dose of the test drug, and are not planning to become pregnant or to donate sperm or eggs; 4) Subjects fully understand the purpose, nature, methods and possible adverse effects of the test, and voluntarily serve as subjects and sign an informed consent form; those who are able to complete the test in accordance with the requirements of the program.
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity or allergy to any of the ingredients of Sildenafil Citrate Dispersible Tablets and Sildenafil Citrate Tablets (allergy means allergy to two or more drugs, food and pollen); 2) Diseases and factors that need to be excluded due to abnormal clinical manifestations, including but not limited to neurological, cardiovascular (e.g., history of myocardial infarction, history of hypotension, postural hypotension, etc.), digestive (e.g., dyspepsia, gastrointestinal ulcers, etc.), hematological and lymphatic, immune, renal, hepatic (e.g., jaundice), respiratory, metabolic, and skeletal conditions, in particular the presence of factors that may significantly affect the absorption, distribution, metabolism, and excretion of medicines. The patient should have a history of medical conditions that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or a history of medical conditions related to the effects of the drug being tested; 3) History of ocular disease (e.g., retinitis pigmentosa, retinal edema, retinal vasculopathy or hemorrhage, vitreous traction or detachment, peripapillary macular edema, history of non-arteritic anterior ischemic optic neuropathy (NAION), color weakness, or history of vision loss); 4) Those with hereditary galactose intolerance, those suffering from Lapp lactase deficiency or glucose-galactose malabsorption; 5) those who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study period, and anyone who has undergone surgery that would interfere with drug absorption, distribution, metabolism, or excretion; 6) Those with dysphagia; 7) Those who cannot tolerate venipuncture, have had difficulty collecting blood from a vein, or have a history of needle and blood phobia; 8) Anyone who has used any prescription drugs, over-the-counter drugs, proprietary Chinese medicines, any herbal products, or health supplements within 2 weeks prior to the administration of the test drug; 9) have used nitrates, alpha and ? receptor blockers, guanylate cyclase agonists (e.g., leucovorin), other PDE5 inhibitors, CYP3A4 and CYP2C9 inhibitors/inducers (e.g., bosentan, carbamazepine, phenytoin sodium, phenobarbital, St. John's wort, rifampicin, ketoconazole, ritonapine), or any other medication in the 4 weeks prior to taking the investigational medication. , ketoconazole, ritonavir, saquinavir, erythromycin, cimetidine, clarithromycin, telithromycin, nefazodone, etc.) and nicorandil; 10) Those with a history of substance abuse within 6 months prior to screening or a positive substance abuse screen; 11) Drug use in the 3 months prior to screening; 12) Any abnormalities in any of the vital signs, physical examination, clinical laboratory tests (routine blood, blood biochemistry, urinalysis, coagulation), pregnancy test (females only), and 12-lead electrocardiogram that are judged by the investigator to be clinically significant; 13) Those who have one or more of Hepatitis B Virus Surface Antigen, Hepatitis C Antibody, HIV (1+2) Antibody + p24 Antigen, and Syphilis Specific Antibody (TP-ELISA) that are clinically significant; 14) Individuals who have smoked more than 5 cigarettes per day or habitually used nicotine-containing products in the 3 months prior to screening and who are unable to give up smoking during the entire study period; 15) who have consumed greater than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of 40%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Cmax;AUC0-8; | — |
Countries
China
Contacts
Public ContactYang Suixin
Huzhou Central Hospital
Outcome results
None listed