单剂量给药人体安全性、耐受性研究;不用抗过敏措施,观察过敏反应发生情况和有效性。
[Translation] A single-dose human safety and tolerance study; no anti-allergic measures were used to observe the occurrence and effectiveness of allergic reactions.
1、评价单剂量给药在人体的安全性、耐受性,为II期临床及以后的临床应用提供理论依据。 2、比较研究本制剂和市售注射液的单次静脉滴注人体药代动力学特征,了解紫杉醇脂质体在人体内的吸收、分布、消除规律,为临床合理用药提供理论依据。 3、单药治疗复发转移乳腺癌客观缓解率、安全性和无进展生存期。
[Translation] 1. Evaluate the safety and tolerability of single-dose administration in humans, and provide a theoretical basis for Phase II clinical trials and subsequent clinical applications. 2. Compare the pharmacokinetic characteristics of single intravenous infusion of this preparation and commercially available injections in humans, understand the absorption, distribution, and elimination of paclitaxel liposomes in the human body, and provide a theoretical basis for rational clinical drug use. 3. Objective remission rate, safety, and progression-free survival of single-drug treatment of recurrent and metastatic breast cancer.
100 Clinical Results associated with Shanghai Tianhui Chemical & Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shanghai Tianhui Chemical & Pharmaceutical Co., Ltd.
100 Deals associated with Shanghai Tianhui Chemical & Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shanghai Tianhui Chemical & Pharmaceutical Co., Ltd.