Bioequivalence between two kinds of amlodipine besilate tablets in healthy volunteers

AIM: To study the bioequivalence between two kinds of amlodipine besilate tablet formulations in healthy human body. METHODS: Eighteen healthy Chinese male volunteers were included in a randomized, cross-over design. All subjects were administered individually a single 10 mg oral dose of each formulation separated by a 14-day washout period. Plasma amlodipine levels were determined by LC/MS/MS assay. The bioavailability and bioequivalence of the formulations were evaluated. RESULTS: The pharmacokinetic parameters of the test and reference tablets were as follows: tmax were (8.9±s 2.5) and (8.2±2.2) h; cmax were (5.1±2.3) and (5.0±2.2)μg·L-1; t1/2 were (45±10) and (49±24) h; AUC0-t were (191±69) and (196±53)μg·h·L-1; AUC0-∞, were (225±79) and (243±89)μg·h·L-1 respectively. The relative bioavailability of the test tablets was (99±23) %. CONCLUSION: The study demonstrated the two formulations having bioequivalence with each other in healthy human body.