Pharmacokinetics and bioequivalence of taurine granules in healthy volunteers

OBJECTIVE To investigate the pharmacokinetics and relative bioavailability of taurine granules in healthy volunteers and evaluate the bioequivalence.METHODS A single oral dose of 1.6 g taurine test and reference granules was given to 20 male healthy volunteers in a randomized,two-way crossover study.The concentration of taurine in serum was determined by high performance liquid chromatogram (HPLC)-fluorescence method.The pharmacokinetic parameters and relative bioavailability were calculated with DAS software to evaluate the bioequivalence of the two preparations.RESULTS The main pharmacokinetic parameters of test and reference preparations were as follows:t1/2(51.0±8.8) and (56.4±11.6)min;tmax (38.0±12.0) and (39.5±10.0)min;Cmax (54.0±8.4) and (54.9±9.5) mg·L-1;AUC0-360 min(5296.88±1123.50) and(5123.8±806.6)mg·min ·L-1;AUC(0-∞(5552.11±1149.57) and(5421.89±820.69)mg·min ·L-1,respectively.The differences of the major pharmacokinetic parameters between test and reference granules were not significant.The relative bioavailability of F was (105.0±26.3)%.CONCLUSION The statistical analysis of the results showed that the two preparations are bioequivalence.