Department of Clinical Pharmacology，Bethune International Peace Hospital of PLA，Shijiazhuang 050082，China
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History+
Received
Published
2007-07-16
2008-06-05
Issue Date
2008-06-05
Abstract
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.
WU Hong-hi;LIU Jin-fng;ZHNG Yun-ho;HOU Yn-ning.
Determination of Tiopronin in Human Plasma and Study on Its Bioequivalence [J]. Chinese Pharmaceutical Journal, 2008, 43(11): 855-857
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