Pharmacokinetics and bioequivalence of fudosteine granules and tablets in healthy volunteers

Objective: To evaluate the pharmacokinetics and bioequivalence 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 pharmacokinetic parameters of the reference and test preparations were as follows: Cmax(10.89±3.45) and(10.99±3.01) μg·mL-1,Tmax(0.43±0.09) and(0.38±0.14) h,t1/2(3.46±0.72) and(3.19±0.70) h,AUC0~t(23.17±7.47) and(23.17±6.64) μg·h·mL-1,AUC0~∞(25.13±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 Cmax,Tmax and AUC.Conclusion: The test and reference preparations of fudosteine are bioequivalent.