Study on Bioequivalence of Ursodexycholic Acid Capsules

OBJECTIVE To evaluate the bioequivalence of ursodexycholic acid capsules(test samples) and imported ursodexycholic acid capsules(reference samples).METHODS 20 Healthy male volunteers were randomly administered with an oral single crossover dose of test and referemce ursodexycholic acid capsules 500 mg.The plasma samples were then collected from volunteers to measure ursodexycholic acid concentrations by HPLC-MS.The pharmacokinetic parameters of ursodexycholic acid casuples were calculated using BAPP2.0 practical pharmacokinetic program.RESULTS The pharmacokinetics of reference and test samples were as follows:tmax(3.0±0.8),(2.8±0.9)h;ρmax(8 565.69±2 692.58),(7 184.87±2 396.34) μg·L-1,AUC0-10(23 488.34±6 594.56),(22 725.19±6 083.04)μg·h·L-1,t1/2(1.53±0.55),(1.56±0.61)h。The relative bioavailability of test samples was(98.5±13.8)%.CONCLUSION The test capsules are bioequivalent to the reference capsules.