Bioequivalent of amlodipine besylate tablets in healthy volunteers

Objective: To investigate the bioequivalence of amlodipine besylate tablets in healthy volunteers.Methods: A single oral dose of 10 mg test or reference formulations were given to 20 male healthy volunteers in a randomized crossover design.The serum concentration of amlodipine was determined by LC-MS/MS method.Pharmacokinetic parameters and relative bioavailability were calculated with DAS 2.0 program to evaluate the bioequivalence of the two formulations.Results: Pharmacokinetic parameters of amlodipine besylate test formulation were obtained as follows:T_max was(5.60±3.09) h,C_max was(8.19±2.2) μg/L,AUC_0-144 was(366±100) μg·L^-1·h^-1,AUC_0-∞ was(397±115) μg·L^-1·h^-1.For reference formulation:T_max was(6.30±2.85) h,C_max was(8.22±1.99)μg/L,AUC_0-144 was(385.8±80) μg·L^-1·h^-1,AUC_0-∞ was(421±83) μg·L^-1·h^-1.Calculated with AUC_0-144,the bioavailability of two formulation was(96.1±26.6)%.Conclusions: The amlodipine besylate tablets test formulation and reference formulation were bioequivalent.