Pharmacokinetics of generic dasatinib in the management of chronic myeloid leukemia in the choronie phase

VernacularTitle:国产达沙替尼治疗慢性髓性白血病慢性期患者的药代动力学研究
Author: Jun KONG ¹ ; Nan CHEN ; Haixia FU ; Taijun HANG ; Min SONG ; Hao JIANG
Author Information

1. 100044,北京大学人民医院、北京大学血液病研究所
Keywords: Dasatinib; Biosimilar pharmaceuticals; Pharmacokinetics; Therapeutic equivalency
From: Chinese Journal of Hematology 2016;37(11):957-960
CountryChina
Language:Chinese
Abstract: Objective To evaluate the pharmacokinetics and bioequivalence of genetic dasatinib in patients with chronic myeloid leukemia in the choronie phase(CML-CP).Methods Using randomized,parallel,overlapping,self-control designed study,a 100 mg dose of the reference or test tablet was given to 12 CML-CP patients who were resistant or intolerant to Imatinib and Nilotinib in a randomized two-way crossover design,and the plasma concentration of the medicine was assayed by HPLC-MS-MS.The main pharmacokinetic parameters and bioequivalence of the two formulations were evaluated.Results The major pharmacokinetic parameters were as follows:Cmax (209.01±58.69) μg/L and (223.07±79.51) μg/L,Tmax (1.1±0.8) h and (1.1±0.8) h,T1/2 (5.10±1.34) h and (4.39±0.74) h,AUC0.t (646.65±185.67) h·μg/L and (695.84±273.40) h·μg/L (all P＞0.05);AUC0-x(668.11±186.00) h·μg/L and (712.42±278.08) h·μg/L,MRT (5.32± 1.70) h and (4.68± 1.53) h (all P＞0.05).Conclusion The two formulations were bioequivalent.