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Clinical Trials associated with Amphotericin B Liposomal(Tide Pharmaceutical) / Not yet recruitingPhase 1 注射用两性霉素B磷脂酰甘油复合物脂质体与注射用两性霉素B脂质体(AmBisome)单次健康人给药的人体药代动力学对比研究
[Translation] Comparative study on the pharmacokinetics of amphotericin B phosphatidylglycerol complex liposomes for injection and amphotericin B liposomes for injection (AmBisome) in healthy subjects after single administration
选择中国健康成年男性志愿者为受试者,获得北京泰德制药股份有限公司生产的注射用两性霉素B磷脂酰甘油复合物脂质体(试验制剂)和原研药的药代动力学参数,比较试验制剂与参比制剂的药代动力学数据,了解药代行为及安全性。为试验制剂申报注册提供支持,同时为临床合理用药提供依据。
[Translation] Healthy adult male volunteers from China were selected as subjects to obtain the pharmacokinetic parameters of amphotericin B phosphatidylglycerol complex liposomes for injection (test preparation) and the original drug produced by Beijing Taide Pharmaceutical Co., Ltd., and to compare the pharmacokinetic data of the test preparation with the reference preparation to understand the pharmacokinetic behavior and safety. This provides support for the registration of the test preparation and a basis for rational clinical drug use.
100 Clinical Results associated with Amphotericin B Liposomal(Tide Pharmaceutical)
100 Translational Medicine associated with Amphotericin B Liposomal(Tide Pharmaceutical)
100 Patents (Medical) associated with Amphotericin B Liposomal(Tide Pharmaceutical)
100 Deals associated with Amphotericin B Liposomal(Tide Pharmaceutical)