[Translation] A single-center, randomized, open-label, single-dose, two-dose, four-period, completely repeated crossover bioequivalence study of atorvastatin calcium tablets in healthy Chinese adult subjects under fasting and fed conditions
主要目的:观察单次口服20mg(空腹/餐后)受试制剂阿托伐他汀钙片(规格:20mg/片,宁波大红鹰药业股份有限公司生产)与参比制剂阿托伐他汀钙片(立普妥®,规格:20mg/片,辉瑞制药有限公司生产)在中国成年健康受试者体内的药代动力学特征,评估空腹与餐后状态下分别口服两种制剂的生物等效性。
次要目的:观察受试制剂和参比制剂单次口服20mg(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of a single oral dose of 20 mg (fasting/after meal) of the test preparation atorvastatin calcium tablets (specification: 20 mg/tablet, produced by Ningbo Dahongying Pharmaceutical Co., Ltd.) and the reference preparation atorvastatin calcium tablets (Lipitor®, specification: 20 mg/tablet, produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy adult Chinese subjects, and to evaluate the bioequivalence of the two preparations in fasting and after meal conditions.
Secondary objective: To observe the safety of a single oral dose of 20 mg (fasting/after meal) of the test preparation and the reference preparation in healthy adult Chinese subjects.