Pharmacokinetics of azelnidipine in healthy volunteers

Objective To investigate the pharmacokinetics of azelnidipine tablets in healthy volunteers. Methods A single oral dose of tablets was given respectively to 10 healthy volunteers who were randomly distributed into two groups(8,16 mg). Drug concentration was determined by HPLC-MS-MS.Results The main pharmaeokinetic parameters(8,16 mg)were as follows:Cmax of the two groups were (5.85±3.27),(23.06±5.63)μgL-1;tmax were(3.00±1.41),(2.55±1.01)h;t1/2(ke)(15.96±5.52),(18.03±1.88)h;AUC0-tnwere (83.83±36.05),(255.98±120.27)μghL-1 ;AUC0-∞ were (89.57±37.34),(272.54±128.36)μghL-1 respectively.Conclusion The value of Cmax and AUC will increase following the increase of the doses. It is showed that the sex-related differences did not exist in the main pharmaeokinetic parameters between males and females by analysis of variance. During the experiment, no adverse reactions happened, which suggested the given doses were safe.