Title: Pharmacokinetics and Bioequivalence of Domestic Nifedipine Controlled Release Tablets
Abstract: 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.
Publication Year: 2005
Publication Date: 2005-01-01
Language: en
Type: article
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