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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 1999, Vol. 4 ›› Issue (3): 202-204.

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Comparative study on bioavailability and bioequivalence of clarithromycin disperse tablets and limaixian tablets in healthy volunteers

GUO Rui-Chen, WANG Ben-Jie, XU Wei-Fen, LI Bo, ZHANG Qing-Yin, MA Xiao-Hui   

  1. Affiliated Hospital of Shandong Medical University, Jinan 250012
  • Received:1999-05-04 Revised:1999-05-31 Online:1999-09-26 Published:2020-11-27

Abstract: Aim The bioavailability and bioequivalence of clarithromycin disperse tablets (as test preparation)and Limaixian tablets (as reference preparation)weRestudied in 8 healthy volunteers with a double-cross design test.Methods The serum concentrations of clarithromycin after a sig le oral dose of 500 mg of the test preparation or reference preparation were determined by microassay method. Datum were analysed with 3p97 pharmacokinetic programme and two-one sidedt test and (1-2α)confidence interval analysis.Results The Ka, t1/2 (α), t1/2(β), Cmax, AUC (0 ~ ∞)of the two preparations were 0.7843 and 0.5893 h-1, 1.7324 and 2.3140 h, 4.1449 and 3.8635 h, 2.2308 and 1.8742μg ·ml-1, 17.7410 and 16.2751 μg · h ·ml-1, respectively.The relative bioavailability of clarith romycin desperse tablet was 106.21 %.Conclusion The bioequivalence of AUC between test and reference preparations, phases and subjects shows no significant differences (P>0.05).

Key words: clarithromycin disperse tablets/limaixian tablets, relative bioavailability, pharmacokinetics

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