Title: Bioequivalence of Felodipine Sustained-release Tablets in Healthy Volunteers
Abstract: Objective To set up a method for determination of felodipine in human plasma by HPLC-MS/MS and study the relative bioavailability and bioequivalence of felodipine sustained-release tablets.Methods Twenty healthy male volunteers were randomized to receive a single dose of tested felodipine sustained-release tablet or the reference tablet by a two-way crossover design.Plasma concentration of felodipine was determined by HPLC-MS/MS and the bioequivalence between two formulations were evaluated by DAS2.0 program.Results The pharmacokinetic parameters of the tested and the reference felodipine tablet were expressed as follows: Cmax was(2.15±0.63) ng·mL-1 and(2.29±0.63) ng·mL-1,tmax was(6.33±1.57) h and(6.68±1.32) h,t1/2 was(18.22±2.75) h and(19.04±2.27) h,AUC0-48 were(58.11±5.15) ng·mL-1·h and(61.13±6.31) ng·mL-1·h.The relative bioavailability F was(95.06±8.42) %.Conclusion The two felodipine sustained-release tablets are bioequivalent.
Publication Year: 2013
Publication Date: 2013-01-01
Language: en
Type: article
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