[Translation] Bioequivalence of atorvastatin calcium tablets in Chinese subjects after randomized, open-label, single-dose, fasting and postprandial administration, two-dose, three-sequence, three-period crossover
观察单次口服40mg(空腹/餐后)受试制剂阿托伐他汀钙片(规格:40mg/片,海南海灵化学制药有限公司)与参比制剂阿托伐他汀钙片(立普妥,规格:40mg/片,辉瑞制药有限公司生产)在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性。
[Translation] To observe the relative bioavailability of a single oral dose of 40 mg (fasting/after meal) of the test preparation atorvastatin calcium tablets (specification: 40 mg/tablet, Hainan Hailing Chemical Pharmaceutical Co., Ltd.) and the reference preparation atorvastatin calcium tablets (Lipitor, specification: 40 mg/tablet, produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy Chinese humans, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations.