2008•Chinese Journal of Modern Drug ApplicationRequires access
Bioequivalence of Tinidaxole-colon-Positioning Enteric-coated Tablets in healthy volunteers
Yang Shui-yua
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Abstract
Objective To inspect the bioequivalence of Tinidaxole-colon-Positioning Enteric-coated Tablets in healthy volunteers.Methods A single(2 g)and multiple(1 g)oral of Enteric-coated Tablets and reference tablets were given to 20 healthy male cvolunteers according to randomized crossover design.Tinidaxole in plasma was determined by HPLC methods.The pharmacokinetic parameters and bioavailability of and reference tables.Results after a single oral of 2 g Enteric-coated Tablets and reference tables,the pharmacokinetic parameters were as follows:AUC0-84 was(881.7±147.5)and(974.5±146.9)mg/(h·L),Cmax was(33.83±6.50)and(47.94±8.68)mg/L,tmax was(10.60±1.93)and(1.63±0.46)h,respectively.The relative bioavailability of Enteric-coated Tablets was(90.91±11.29)%.After multiple oral administration 1 g Enteric-coated Tablets and reference tables,the pharmacokinetic parameters were as follows:AUC0-84 was(1277.9±289.8)and(1191.6±288.0)mg/(h·L),Cmax was(47.74±10.34)and(55.14±9.01)mg/L,tmax was(10.06±1.86)and(1.44±0.64)h,respectively.The relative bioavailability of Enteric-coated Tablets was(109.55±20.58)%.Conclusion The 2 preparations are bioequivalent.