Zhejiang Anglikang Pharmaceutical Co. Ltd.

A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, 2-sequence, 4-period, repeated crossover bioequivalence study of ezetimibe atorvastatin calcium tablets developed by Zhejiang Anlikang Pharmaceutical Co., Ltd. and ATOZET® marketed by Merck Sharp & Dohme in healthy subjects

Main purpose: Using Mosapride Citrate Tablets (Specification: 5 mg) of Zhejiang Anlikang Pharmaceutical Co., Ltd. as the test preparation and Mosapride Citrate Tablets (Specification: 5 mg) of Sumitomo Dainippon Pharma Co., Ltd. as the reference preparation, according to the relevant provisions of bioequivalence test, the bioequivalence of the two preparations in healthy subjects was investigated. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

To investigate the in vivo pharmacokinetic characteristics of fluvastatin sodium sustained-release tablets (specification: 80 mg) produced by Zhejiang Anlikang Pharmaceutical Co., Ltd. and fluvastatin sodium sustained-release tablets (trade name: Lescol® XL, specification: 80 mg) produced by Novartis Pharmaceuticals Corp. under fasting/postprandial conditions in healthy Chinese subjects, and to evaluate the bioequivalence of fluvastatin sodium sustained-release tablets produced by Zhejiang Anlikang Pharmaceutical Co., Ltd. and fluvastatin sodium sustained-release tablets produced by Novartis Pharmaceuticals Corp. The safety of the test and reference preparations of single-dose oral fluvastatin sodium sustained-release tablets (specification: 80 mg) in healthy Chinese subjects was evaluated.