Research Article
Vargas M and Villarraga E
Abstract
The presented results correspond to a pharmacokinetic study in healthy Colombian volunteers, of two Dasatinib 100 mg formulations: The Test Product is Dasatinib from Synthesis Laboratory, and the Reference Product is Sprycel® Dasatinib from Bristol-Meyers Squibb Laboratory. The design was an open, longitudinal, randomized, comparative study of two formulations in single dose of 100 mg, with a 7 days washout in between doses. Quantification was performed using validated by Delivery Technologies Laboratories high resolution liquid chromatography, coupled to ultraviolet detector, HPLC-UV, for plasma Dasatinib identification and quantification. The main pharmacokinetic parameters were similar for both studied formulations: Cmax 127.5 vs. 122.5 ng/mL, tmax 1.0 vs. 1.6 h, AUC0-t 417.6 vs. 409.2 hr*ng/mL, and AUC0-inf 425.5 vs. 416.9 h*ng/mL, Test Product vs. Reference Product. By bringing these parameters to statistical analysis, 90% confidence intervals were found for the parameters requested by the national regulatory agency INVIMA and the internationals FDA and EMA. The 90% confidence intervals found for the relation Test/Reference, were Cmax 84.6-116.1, AUC0-t 88.2-108.9 and AUC0-inf 87.9 -108.4. According to European and FDA´s guidelines for Bioequivalence research, confidence intervals ranged between the allowed values to declare Bioequivalence and interchange ability of Test Product from Synthesis Laboratory with Reference Product.