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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2006, Vol. 11 ›› Issue (1): 66-69.

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Study of pharmacokinetics of secnidazole vagina effervescent tablets in healthy volunteers

WANG Shao-hua, ZHAO Yan, LIU Zhen-sheng, LI Zhi-ping, WANG Xia1 , ZHAO Mei-ling, QI Fang-mei   

  1. Base for Drug Clinical Trial, 1Department of Gynaecology and Obstetrics, Qingdao Municipal Hospital, Qingdao 266011, Shandong, China
  • Received:2005-11-23 Revised:2005-12-07 Online:2006-01-06 Published:2020-10-23

Abstract: AIM:To study the pharmacokinetics of secnidazole vagina effervescent tablets in healthy volun- teers.METHODS :250, 500 and 750 mg secnidazole vagina effervescent tablets were used in single-dose groups;500 mg secnidazole vagina effervescent tablets were used for 7 days in multi-dose group .The concentra- tions of secnidazole in plasma were determined by HPLC . The parameters of pharmacokinetics were calculated by DAS software .RESULTS AND CONCLUSION:The pharmacokinetic parameters after administration of a single dose of secnidazole vagina effervescent tablets( 250, 500, 750 mg) in health married female volunteers were as fol- lows :T1/ 2β were 18 .84, 15 .25, and 21 .86 h, in accor- dance with the literatures ;Tmax were 12 .22, 14 .00, and 18 .00 h ;Cmax were 3 .58, 5 .42, and 8 .00 mg·L -1 ; AUC were 103 .52, 190 .99, and 296 .92 mg·h-1·L -1 , respectively.The absorption of secnidazole vagina effer- vescent tablets was slower and lower than oral tablets . The systemic actions and adverse reactions were fewer and rudimental concentrations were higher so as to show more local actions .The pharmacokinetic parameters after ad- ministration of multi doses of secnidazole vagina efferves- cent tablets ( 500 mg ) were as follows :T1/2β =22 .74 h, Cmax =14 .30 mg·L-1 , Tmax =11 .60 h, and AUC = 520 .14 mg·h-1·L -1 .Cmax and AUC were higher than the results of a single dose.These showed that the drug can cumulate after a long-time administration because of its long half-life and required more caution .

Key words: secnidazole , effervescent tablets , phar- macokinetics, plasma concentration , high performance liquid chromatography (HPLC)

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