Compare of pharmacokinetics of nifedipine sustained release tablets and nifedipine tablets in healthy volunteers

AIM To compare the pharmacokinetics of nifedipine sustained release tablets and nifedipine tablets in healthy volunteers.METHODS Twelve healthy male volunteers were divided into two groups,and received a single oral dose of nifedipine sustained release tablets and nifedipine tablets 20 mg,respectively.The plasma concentrations of nifedipine were determined by HPLC,and the pharmacokinetic parameters were calculated by DAS 2.1 software.RESULTS The pharmacokinetic parameters of nifedipine sustained release tablets and nifedipine tablets were as follows:ρmax were(1 247.8 ± 78.4)μg·L-1 and(1 896.7 ± 109.2)μg·L-1,tmax were(4.6 ± 0.7)h and(2.6 ± 0.9)h,t1/2 were(8.6 ± 2.8)h and(4.8 ± 1.5)h,AUC0-∞ were(5 879.3 ± 176.2)μg·h·L-1 and(3 724.9 ± 121.3)μg·h·L-1,AUC0-t were(4 427.8 ± 131.7)μg·h·L-1 and(2 936.5 ± 75.4)μg·h·L-1 respectively.The tmax and t1/2 of nifedipine sustained release tablets were significantly longer than that of nifedipine tablets,AUC0-t and AUC0-∞ were significantly higher than that of the nifedipine tablets,and ρmax was significantly lower than that of nifedipine tablets.CONCLUSION The nifedipine sustained release tablets have the sustained-release characteristics.