Nanjing Kangchuanji Pharmaceutical Technology Co., Ltd.

This study aims to study the pharmacokinetic characteristics of rosuvastatin ezetimibe tablets (I) (10 mg:10 mg) after single oral administration on an empty stomach or after a meal: using rosuvastatin ezetimibe tablets (I) (10 mg:10 mg) certified by Sanofi-Aventis Deutschland GmbH as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Main research purpose: According to the relevant provisions of bioequivalence test, the sildenafil citrate orodisintegrating tablets (trade name: Viagra®, specification: 50mg (calculated as C22H30N6O4S)) with Upjohn EESV as the licensee was selected as the reference preparation, and the test preparation sildenafil citrate orodisintegrating tablets (specification: 50mg (calculated as C22H30N6O4S)) produced by Zhejiang Siwei Pharmaceutical Technology Co., Ltd. and licensed by Nanjing Kangchuanji Pharmaceutical Technology Co., Ltd. was subjected to human bioequivalence test under fasting administration conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation sildenafil citrate orodisintegrating tablets (strength: 50 mg (calculated as C22H30N6O4S)) and the reference preparation sildenafil citrate orodisintegrating tablets (trade name: Viagra®, strength: 50 mg (calculated as C22H30N6O4S)) to healthy subjects.