/ CompletedNot Applicable 注射用白蛋白紫杉醇与注射用紫杉醇(白蛋白结合型)(Abraxane)人体生物等效性试验
[Translation] Bioequivalence study of nab-paclitaxel for injection and paclitaxel for injection (albumin-bound) (Abraxane) in humans
主要目的:研究浙江海正药业股份有限公司研制生产的注射用白蛋白紫杉醇和参比制剂注射用紫杉醇(白蛋白结合型)(Abraxane)的人体生物等效性。次要目的:评价浙江海正药业股份有限公司生产的注射用白蛋白紫杉醇的安全性和有效性。
[Translation] Primary objective: To study the bioequivalence of nab-paclitaxel for injection developed and produced by Zhejiang Hisun Pharmaceutical Co., Ltd. and the reference preparation paclitaxel for injection (albumin-bound) (Abraxane) in humans. Secondary objective: To evaluate the safety and efficacy of nab-paclitaxel for injection produced by Zhejiang Hisun Pharmaceutical Co., Ltd.
100 Clinical Results associated with Nanjing Yifang Pharmacy Research&Development Center Co.,Ltd.
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100 Deals associated with Nanjing Yifang Pharmacy Research&Development Center Co.,Ltd.
100 Translational Medicine associated with Nanjing Yifang Pharmacy Research&Development Center Co.,Ltd.