罗沙司他胶囊随机、开放、两制剂、两周期、交叉、健康人体空腹和餐后生物等效性试验
[Translation] A randomized, open-label, two-dose, two-period, crossover bioequivalence study of rosuvastatin capsules in healthy volunteers with fasting and fed diet
主要目的:研究健康受试者在空腹/餐后状态下,单次口服由河北紫薇山制药有限责任公司生产的罗沙司他胶囊50mg(受试制剂)和珐博进(中国)医药技术开发有限公司为持证商的原研罗沙司他胶囊50mg(Roxadustat Capsules/爱瑞卓®,参比制剂)的相对生物利用度,评价受试制剂与参比制剂间的生物等效性。
次要目的: 通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况观察受试制剂和参比制剂在中国健康受试者中的安全性和耐受性。
[Translation] Primary objective: To study the relative bioavailability of 50 mg roxadustat capsules (test preparation) produced by Hebei Ziweishan Pharmaceutical Co., Ltd. and 50 mg roxadustat capsules (Roxadustat Capsules/Airizhuo®, reference preparation) produced by Fibrogene (China) Pharmaceutical Technology Development Co., Ltd. (reference preparation) in healthy subjects after a single oral administration in fasting/postprandial state, and to evaluate the bioequivalence between the test preparation and the reference preparation.
Secondary objective: To observe the safety and tolerability of the test preparation and the reference preparation in healthy Chinese subjects through changes in adverse event incidence, laboratory test results, vital signs and physical examinations.
100 Clinical Results associated with Hebei Ziweishan Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hebei Ziweishan Pharmaceutical Co., Ltd.
100 Deals associated with Hebei Ziweishan Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hebei Ziweishan Pharmaceutical Co., Ltd.