Nanjing Jinling Pharmacy Co., Ltd.

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.

A two-period repeated crossover study was conducted in which 12 healthy subjects took oral doses of atorvastatin calcium tablets (trade name: Lipitor) produced by Pfizer Pharmaceuticals Co., Ltd., which is marketed in China, repeatedly. The pharmacokinetic parameters and intra-individual coefficient of variation of atorvastatin calcium and its metabolites were investigated to provide a basis for the design of a formal human bioequivalence study of atorvastatin calcium dispersible tablets.