Determination of Tiopronin in Human Plasma and Study on Its Bioequivalence

OBJECTIVE To study the pharmacokinetics and bioequivalence of tiopronin tablets in healthy volunteers.METHODS In a randomized crossover study,18 healthy male volunteers were given a single oral dose of 200 mg test and reference tablets.Tiopronin in plasma was determined by a LC-MS method.RESULTS The main pharmacokinetic parameters for tiopronin of reference and test preparations in plasma were as follows:ρmax were(3.54±0.75) and(3.27±1.03) mg·L-1;tmax were(4.6±1.1) and(4.3±1.0) h;AUC0-96 h were(18.2±4.5) and(17.6±5.9) mg·h·L-1;AUC0-∞ were(20.4±5.5) and(19.9 ± 6.9) mg·h·L-1;t1/2 were(39.4±14.3) and(41.8±16.5) h,respectively.The relative bioavailability of tiopronin was(95.7±26.1)%.CONCLUSION The test and reference preparations were bioequivalent.