Assessment of pharmacokinetics and bioequivalence of amlodipine besylate in healthy volunteers

AIM: To study the pharmacokinetics parameters and bioavailability of amlodipine besylate tablets.METHODS: An open,randomized and two-period crossover study with a two-week washout interval was performed in 18 healthy volunteers.Concentrations of amlodipine besylate in plasma were assayed by liquid chromatographic-mass-mass spectrometric method after a single(oral) dose of 10 mg of the tested or the referenced tablets. The pharmacokinetics parameters,AUC,T_(max) and C_(max) were analyzed by two one-side t test and(1-2α) 90%.RESULTS: The main pharmacokinetics of the tested and referenced tablets were: T_(max):(8.9±2.5) and(8.2±2.2) h;C_(max):(5.1±2.3) and((5.0±)2.2) g/L;T_(1/2):(45±10) and(48±24) h;AUC_((0-120 h)):(191±69) and(196±53) μg/(L·h).The relative bioavailiability of amlodipine besylate was(99±23)%.(CONCLUSION:) The results of the statistical analysis show that the two formulations are bioequivalent.