Pharmacokinetics and Bioequivalence of Domestic Nifedipine Controlled Release Tablets

ObjectiveTo investigate the pharmacokinetics and bioequivalence of domestic and imported nifedipine controlled release tablets.Methods According to randomized crossover design, 18 health man volunteers were taken a single oral dose or multiple dosing of 30 mg nifedipine controlled release tablets.Plasma concentration of nifedipine was determinetd by RP-HPLC.ResultsThe pharmacokinetics parameters for the single oral dose of domestic and imported nifedipine controlled release tablet were C max (27.5±15.9)ng/mL and (29.9±11.9)ng/mL;T max (9.9±6.8) h and (9.5±6.6) h, AUC 0→t (686.1±253.3) ng/h·L and (675.0±262.9) ng/h·L.The relative bioavailability for the domestic formulation was 102.8%±13.3%(n=18).For the multiple dosing, the AUC 0→t were (686.1±253.3)ng/h·mL and (675.0±262.9)ng/h·mL, and the relative bioavailability for the domestic formulation was 102.9%±13.8%(n=18).ConclusionThese data showed that the domestic formulation was bioequivalent to imported formulation.