Pharmacokinetics of amlodipine besylate/atorvastatin calcium combination tablet in healthy volunteers

OBJECTIVE To study the pharmacokinetics of combination tablets containing amlodipine besylate/atorvastatin calcium in healthy volunteers.METHODS Thirty healthy volunteers(half male-half female)were divided into three groups.Each ten volunteers received a different dose strengths combination tablets(amlodipine/atorvastatin 5 mg/ 10 mg,10 mg/ 10 mg,5 mg/ 20 mg),respectively.The plasma concentrations of amlodipine and atorvastatin were measured by a fully validated LC-MS/MS method.The pharmacokinetic parameters were calculated thereafter in order to study the pharmacokinetic charateristics of amlodipine and atorvastatin in human.RESULTS The following data were the main pharmacokinetic parameters.Amlodipine(5 mg/ 10 mg),Cmax(3.14±0.46)μg·L-1,AUC0-120(131±22);10 mg/10 mg,Cmax(6.85±1.17)μg·L-1,AUC0-120(327±110)μg·h·L-1;5 mg/ 20 mg,Cmax(3.11±0.47)μg·L-1,AUC0-120(130±16)μg·h·L-1;atorvastatin,5 mg/10 mg,Cmax(11.3±6.7)nμg·L-1,AUC0-120(133.8±93.3);10 mg/10 mg,Cmax(16.7±12.1)μg·mL-1,AUC0-120(107.7±60.4)μg·h·L-1;5 mg/20 mg,Cmax(15.0±9.4)μg·L-1,AUC0-120(147.3±59.3)μg·h·L-1.CONCLUSION In all the three dose groups,Cmax and AUC of amlodipine increased in a dose-dependent manner.Atorvastatin coincide with non-linear pharmacokinetic characteristics.