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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date04 Oct 1991 |
以G-CSF为基础用药评价普乐沙福注射液与安慰剂比较治疗NHL和MM患者自体造血干细胞移植中动员和采集CD34+细胞 安全性及有效性
[Translation] Evaluation of the safety and efficacy of plerixafor injection versus placebo in the mobilization and collection of CD34+ cells in autologous hematopoietic stem cell transplantation in patients with NHL and MM based on G-CSF
评价G-CSF+普乐沙福注射液用于非霍奇金淋巴瘤患者(NHL)和多发性骨髓瘤患者(MM)自体移植前干细胞动员,与G-CSF+安慰剂相比,在4天或者4天以内达到CD34+细胞≥ 5×106/kg的患者比例 。
[Translation] To evaluate the use of G-CSF + plerixafor injection for stem cell mobilization before autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM), and the proportion of patients achieving CD34+ cells ≥ 5×106/kg within 4 days or less compared with G-CSF + placebo.
以粒细胞集落刺激因子(G-CSF)为基础用药普乐沙福注射液在非霍奇金淋巴瘤患者中的药代动力学与药效学研究
[Translation] Pharmacokinetics and pharmacodynamics of plerixafor injection based on granulocyte colony stimulating factor (G-CSF) in patients with non-Hodgkin's lymphoma
以G-CSF( 5μg/kg/天[仅限格拉诺赛特Granocyte ®])为基础用药,考察普乐沙福注射液(0.24mg/kg)在非霍奇金淋巴瘤受试者(NHL) 单次皮下给药自体移植前干细胞动员中的吸收、分布、代谢与排泄过程的药代动力学特征、药效学以及初步的安全性研究。
[Translation] This study was conducted to investigate the pharmacokinetic characteristics, pharmacodynamics, and preliminary safety of plerixafor injection (0.24 mg/kg) in the absorption, distribution, metabolism, and excretion of a single subcutaneous dose of G-CSF (5 μg/kg/day [Granocyte ® only]) in subjects with non-Hodgkin's lymphoma (NHL) for stem cell mobilization prior to autologous transplantation.
100 Clinical Results associated with Hunan Wuhzoutong Pharmacuetical Co. Ltd.
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100 Translational Medicine associated with Hunan Wuhzoutong Pharmacuetical Co. Ltd.