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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2002, Vol. 7 ›› Issue (6): 500-503.

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Pharmacokinetics and relative bioavailability of domestic propylthiouracil tablets in Chinese healthy male volunteers

TANG Cheng, ZHANG Xuan-Hong, ZENG Gui-Xiong, HUANG Li-Hui, LIAO Xiao-Xing, HUANG Min   

  1. Department of Clinical Pharmacology,School of Pharmaceutical Sciences,Sun Yat-sen University,Guangzhou 510080
  • Received:2002-07-11 Revised:2002-07-31 Online:2002-12-26 Published:2020-11-20

Abstract: AIM: To study the pharmacokinetics and relative bioavailability of propylthiouracil tablet in Chinese healthy male volunteers.METHODS: The bioequivalence and relative bioavailability of a test domestic formulation of propylthiouracil in comparison with a reference imported formulation was investigated in a randomized 2-way cross-over study in 20 healthy volunteers following a single oral dose of 200 mg.The washout period was 1wk.Plasma concentrations of propylthiouracil were determined by a HPLC system equipped with a ultraviolet detector.RESULTS: The following pharmacokinetical parameters were derived from the individual plasma concentration time courses.The main parameters for test and reference formulations,Cmax were(5.7±1.5)and(5.8±1.8)mg·L-1;tmax were(1.4±0.8)and(1.4±0.7)h;t1/2were 1.7±0.3 and(1.7±0.2)h;AUC0-t were(18.0±4.4)and(17.8±4.6)mg·h·L-1;AUC0-∞were(18.1±4.5)and(17.9±4.7)mg·h·L-1,respectively.Compared with reference formulation,the relative bioavailability(F)of test formulation was(101.9±13.2)%。The above parameters obtained from two formulations were compared by analysis of variance(ANOVA)and no significant difference was found.The bioequivalence of two formulations was found assessed by two one-side ways test(p<0.05).CONCLUSION: Therefore,from the results of this study it can be concluded that the test formulation is bioequivalent with the referenceformulation.

Key words: propylthiouracil, bioavailability, HPLC

CLC Number: