An open-label, balanced, randomized, two treatments, two sequences, four periods, fully replicate, crossover study to evaluate the bioequivalence of Dasatinib 100 mg film-coated tablets of Abbott Laboratories versus Sprycel® (Dasatinib) 100 mg filmcoated tablets of Bristol-Myers Squibb under both fasting and fed condition in healthy subjects - Abstract
SPRYCEL (dasatinib) is a kinase inhibitor used in the treatment of Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase, Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy. The purpose of this study was to evaluate the bioequivalence between Dasatinib 100 mg filmcoated tablets of Abbott Laboratories versus Sprycel® (Dasatinib) 100 mg film-coated tablets of Bristol-Myers Squibb under both fasting and fed condition in healthy subjects. An open-label, balanced, randomized, two treatments, two sequences, four periods, fully replicate, crossover single dose study with washout period of 02 days under both fasting and fed condition was carried out in 40 subjects in the age group of 22 to 43 years and 32 subjects in fasting and 37 subjects in fed study completed all four periods of the study. The pharmacokinetic samples collected from subjects who completed the study were analysed to determine the plasma concentration of Dasatinib using a validated bio-analytical method.
In the fasting condition, the ISCV of Cmax for reference product was calculated to be 104.94%, hence, 90% confidence interval limit was widened using scaled-averagebioequivalence and the value obtained 72.44% -
23.72% was found to be within the widened limits of 69.84% to 143.19%.
90% confidence interval of AUC0-t was 84.84% - 116.94%, which was within the acceptable limits of 80.00% to 125.00%.
In the fed condition, 90% confidence interval of Cmax and AUC0-t were 102.34% - 120.53% and 100.72% - 112.80% respectively, which were found to be within the acceptable Limits.