In order to compare the
pharmacokinetics parameters of the domestic
Buflomedil hydrochloride tablet with the imported Fonzylane
tablet and obtained the bioavailability of domestic
Buflomedil hydrochloride tablet and provide the theoretical basis for the reasonable use of the drug in the clinic, the 12 healthy male volunteers were divided into two groups by the randomized crossover method, the test group and the control group. A single oral dose 300mg of domestic Buflomedil hydrochloride tablet or imported Fonzylane tablet was given to each group respectively. The serum concentrations were determined with HPLC. The serum concentration time parameters were analyzed by 3P97 computer software and obtained the relevant
pharmacokinetics parameters and the relative bioavailability. Took domestic buflomedil hydrochloride tablet concentration time curve fitted one compartment model. The main pharmacokinetics parameters of domestic Buflomedil hydrochloride and imported Fonzylane tablets were as follows respectively. Cmax=(1.95±0.42)mg/L and (2.00±0.57)mg/L, Tmax=(2.42±0.63)h and (2.48±0.46)h,AUC=(16.16±3.46)mg/L·h,and (16.21±2.82)mg/L·h. Compared the domestic Buflomedil hydrochloride tablet with the imported Fonzylane tablet and obtained the bioavailability: (100.7±19.1)%. As the result of analysis of variance and (1 2a) confidential interval, two one side test, the AUC values of the two formulations were no significant difference between the formulations, periods and individuals. It proved that domestic Buflomedil hydrochloride tablet and imported Fonzylane tablet were bioequivalent.