[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of atorvastatin calcium dispersion in humans under fasting and postprandial administration conditions
以金陵药业股份有限公司南京金陵制药厂提供的阿托伐他汀钙分散片为受试制剂,按有关生物等效性试验的规定,与国内上市的辉瑞制药有限公司生产的阿托伐他汀钙片(商品名:立普妥,参比制剂)进行空腹和餐后人体生物利用度与生物等效性试验,计算受试制剂的相对生物利用度,比较两种制剂的生物等效性。
[Translation] Atorvastatin calcium dispersible tablets provided by Nanjing Jinling Pharmaceutical Factory of Jinling Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence tests, fasting and postprandial human bioavailability and bioequivalence tests were conducted with atorvastatin calcium tablets (trade name: Lipitor, reference preparation) produced by Pfizer Pharmaceuticals Co., Ltd., which is listed in China. The relative bioavailability of the test preparation was calculated, and the bioequivalence of the two preparations was compared.