[Translation] Rosuvastatin Calcium Tablets Bioequivalence Study in Single-center, Randomized, Open-label, Single-dose, Two-period, Double-Crossover Fasting/Fed State in Healthy Subjects
主要研究目的:研究空腹/餐后状态下单次口服受试制剂瑞舒伐他汀钙片(规格:10mg,瀚晖制药有限公司持有)与参比制剂瑞舒伐他汀钙片(Crestor®,规格:10mg;AstraZeneca UK limited. 持有)在健康成年受试者体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:研究瑞舒伐他汀钙片10mg受试制剂和参比制剂在健康成年受试者中的安全性。
[Translation] The main purpose of the study: To study the single oral administration of the test preparation Rosuvastatin Calcium Tablets (Specification: 10mg, held by Hanhui Pharmaceutical Co., Ltd.) and the reference preparation Rosuvastatin Calcium Tablets (Crestor®, Specification: 10mg; owned by AstraZeneca UK limited.) Pharmacokinetics in healthy adult subjects, to evaluate the bioequivalence of the two preparations orally in the fasting/fed state.
Secondary research purpose: To study the safety of rosuvastatin calcium tablets 10 mg test preparation and reference preparation in healthy adult subjects.