title: [Pharmacokinetics of generic dasatinib in the management of chronic myeloid leukemia in the choronie phase].
abstract: Objective:To evaluate the pharmacokinetics and bioequivalence of generic 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-τ(646.65±185.67) h·μg/L and (695.84±273.40) h·μg/L (allP>0.05); AUC0-∝(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 (allP>0.05).Conclusion:The two formulations were bioequivalent.
authors.affiliation: Institute of Hematology, Peking University People's Hospital Beijing 100044, China.
authors.forename: J
authors.initials: J
authors.lastname: Kong
authors.forename: N
authors.initials: N
authors.lastname: Chen
authors.forename: H X
authors.initials: HX
authors.lastname: Fu
authors.forename: T J
authors.initials: TJ
authors.lastname: Hang
authors.forename: M
authors.initials: M
authors.lastname: Song
authors.affiliation: Institute of Hematology, Peking University People's Hospital Beijing 100044, China.
authors.forename: H
authors.initials: H
authors.lastname: Jiang
mesh_terms: D018592:Cross-Over Studies; D000069439:Dasatinib / Q000627:therapeutic use*; D016568:Drugs, Generic; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive; D011743:Pyrimidines / Q000627:therapeutic use; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic; D011743:Pyrimidines; D013607:Tablets; D000068877:Imatinib Mesylate; C498826:nilotinib; D000069439:Dasatinib