Pharmacokinetics and bioequivalence of fudosteine granules and tablets in healthy volunteers
WEI Xiao-ming
ZHAO Na
SONG Dong-mei
ZHANG Xuan
XIE Ai-fang
YU Yan-jing
LIN Chun
YAN Dong
Abstract：Objective:To evaluate the pharmacokineties and bioequivalenee of two preparations of fudosteine.Methods:In a randomized,crossover and self-control study,20 healthy male volunteers were given a single oral dose(400 mg)of test(granules)and reference(tables)prepatations.Serial plasma samples were analyzed by HPLC-MS/MS.Pharmacokinetic parameters were calculated and compared statistically to evaluated bioequivalence between the two preparations using DAS 2.1 program.Results:The major pharmacokinetie parameters of the reference and test preparations were as Allows:C_( max) (10.89±3.45)and(10.99 4-3.01)μg·mL~(-1),T_( max) (0.43 4±0.09)and(0.38 4±0.14)h,t_(1/2) (3.46 4±0.72)and(3.19 4±0.70)h,AUC_(0～t) (23.17±7.47)and(23.17 4±6.64)μg·h·mL~(-1),AUC_(0～∞) (25.13 4±7.63)and(24.97±6.94)μg·h·mL~(-1).The relative bioavailability of two preparations was(101.5±11.2)%.No significant differeneces between the two preparations were found in C_(max),T_(max)and AUC.Conclusion:The test and reference preparations of fudosteine are bioequivalent.
Keywords：fudosteineHPLC-MS/MSpharmaeokineficsbioequivalencegranulestablets
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)