Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

Exclusion Criteria

• •1. Persons with a known history of allergy, allergic disorder or hypersensitivity to the test product and any of its components or related agents;
• •2. Persons with a clear history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic disorders (e.g. hyperkalemia) or other diseases that are not suitable for participation in clinical trials (e.g. history of psychiatric disorders, etc.);
• •3. Those who have donated blood or lost ≥ 400 mL of blood within 3 months prior to enrollment;
• •4. Those who have taken any medication within 2 weeks prior to screening;
• •5. Those who have participated in other drug clinical trials within 3 months prior to enrollment;
• •6. current or former drug abuser or alcohol addict who consumes alcohol at least 2 times a day or 14 or more times a week, or is an avid drinker (1 drink defined as 125 mL of wine, 220 mL of beer or 50 mL of liquor; alcoholism defined as 5 or more drinks in approximately 2 hours);
• •7. Those who smoked more than 10 cigarettes per day during the 3 months prior to screening;
• •8. Hepatitis B surface antigen (HBsAg), HCV antibodies, syphilis spirochete antibodies and HIV antibody-positive persons;
• •9. Those with positive drug abuse screening results or alcohol breath test results;
• •10. Those with positive pregnancy test results(female)；
• •11. Those who have other factors that the investigator considers unsuitable for participation in the trial.