The pharmacokinetics and bioequivalence study of nimodipine tablets

OBJECTIVE To study the pharmacokinetics and relative bioavailability of nimodipine tablets, and to evaluate the bioequivalence.METHODS A single dose 120 mg of domestic or imported nimodipine tablets was given to 24 healthy volunteers in a randomized crossover study. The concentrations of nimodipine in serum were determined by HPLC. The pharmacokinetic parameters as well as relative bioavailability were measured.RESULTS The concentration-time curves of nimodipine were confirmed to one-compartment model. The main pharmacokinetic parameters of domestic and imported nimodipine were as follows: C max were ( 83.9± 15.4) μg·L -1 and ( 83.5± 12.8) μg·L -1,T max were ( 0.57± 0.06) h and ( 0.67± 0.08) h,T 1/2kewere ( 1.80± 0.16) h and ( 1.69± 0.17) h,AUC 0-t were ( 160.9± 15.8) μg·h·L -1 and ( 156.2± 18.7) μg·h·L -1, respectively. The relative bioavailability of domestic nimodipine tablet was ( 108.0± 7.2)%.CONCLUSIONS The results of the statistical analysis showed that the two formulations were bioequivalent.