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

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 (all P>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 (all P>0.05).

Conclusion

The two formulations were bioequivalent.