瑞舒伐他汀钙胶囊随机、开放、两周期、两交叉单次空腹/餐后状态下中国成年健康受试者人体生物等效性试验
[Translation] A randomized, open-label, two-period, two-crossover single-dose bioequivalence study of rosuvastatin calcium capsules in healthy Chinese adult subjects under fasting/fed conditions
考察健康受试者空腹/餐后单次口服受试制剂瑞舒伐他汀钙胶囊(西安葛蓝新通制药有限公司生产,规格:10mg/粒)的人体药代动力学特征,并以已上市的瑞舒伐他汀钙片(商品名:可定/Crestor;阿斯利康药业有限公司生产,规格:10mg/片)为参比制剂,两周期两交叉设计进行人体生物等效性研究,并观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The pharmacokinetic characteristics of the test preparation rosuvastatin calcium capsules (produced by Xi'an Ge Lan Xin Tong Pharmaceutical Co., Ltd., specification: 10 mg/capsule) were investigated in healthy subjects after a single oral administration on an empty stomach or after a meal. The marketed rosuvastatin calcium tablets (trade name: Crestor; produced by AstraZeneca Pharmaceuticals Co., Ltd., specification: 10 mg/tablet) were used as the reference preparation. A two-period, two-crossover design was used to conduct a human bioequivalence study, and the safety of the test preparation and the reference preparation in healthy subjects was observed.
研究受试者分别在空腹和餐后状态下单次口服受试制剂或参比制剂后的药代动力学参数,评价两制剂的生物等效性
[Translation] The pharmacokinetic parameters of the test preparation or reference preparation after a single oral administration in the fasting and fed state were studied to evaluate the bioequivalence of the two preparations.
研究受试者分别在空腹和餐后状态下单次口服常州制药厂有限公司生产的瑞舒伐他汀钙片(T,5 mg/片)与IPR PHARMACEUTICALS INCORPORATED生产、阿斯利康制药有限公司分装的瑞舒伐他汀钙片(R,可定,5 mg/片)后的相关药代动力学参数,评价两制剂的生物等效性。
[Translation] The relevant pharmacokinetic parameters of rosuvastatin calcium tablets (T, 5 mg/tablet) produced by Changzhou Pharmaceutical Factory Co., Ltd. and rosuvastatin calcium tablets (R, Crestin, 5 mg/tablet) produced by IPR PHARMACEUTICALS INCORPORATED and packaged by AstraZeneca Pharmaceuticals Co., Ltd. were compared after a single oral administration in the fasting and fed states, and the bioequivalence of the two preparations was evaluated.
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