Abstract:
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.