Bioequivalence of domestic and imported ursodeoxycholic acid capsules in healthy volunteers

Objective To evaluate the bioequivalence of ursodexycholic acid capsules improved by a company comparing with the reference produced by Dr.Falk Pharma GmbH.Methods 21 healthy male volunteers were randomly administered with an oral single crossover dose of test.The concentrations of ursodexycholic acid in plasma were determined by LC-MS using cetirizine hydrochloride as internal standard.Results The AUC0-24h were(18.9±7.0)and(19.0±5.5) mg·h·L-1;AUC0-∞ were(22.6±11.8) and(20.9±5.9) mg·h·L-1;tmax were(2.4±0.4) and(2.3±0.6)h;Cmax were(9.2±5.0) and(8.2±4.0)mg·L-1,respectively for test and reference after an oral single dose of 500 mg ursodexycholic acid capsules.There were no significant difference between the main pharmacokinetic parameters and the relative bioavailability of the test was(104.4±38.3)%.Conclusion It is bioequivalent for the test capsules comparing with the reference capsules after a single oral dose of 500 mg ursodexycholic acid capsules.