Knowledge Network Node
Chinese Journal of Hospital Pharmacy. 2014, (19) Core

Bioequivalence of candesartan cilexitel tablets in healthy volunteersChinese Full Text

HOU Jian-ping;XIONG Xue-feng;KUANG Sai-ling;HU Jin-qing;NI Xiao-jia;ZHANG Ming;SHANG De-wei;WEN Yu-guan;Department of Clinical Pharmacy,First People’s Hospital of Baiyun District;State Drug Clinical Trial Agency,Guangzhou Brain hospital;

Abstract: OBJECTIVE To study the bioequivalence of candesartan cilexetil tablets manufactured in China among healthy volunteers.METHODS Eight milligrams test preparations（four milligrams tablet and eight milligrams tablet respectively）and reference preparation were given to 30 male healthy volunteers in a randomized three-period three-preparation two-way crossover design for the pharmacokinetic and bioequivalence study.Plasma concentrations of candesartan were determined by the detective method of high performance liquid chromatography-Mass/Mass.RESULTS The primary pharmacokinetic parameters of three preparations were:Cmax（92.24±29.15）μg·L-1,（94.72±33.17）μg·L-1 and（92.06±28.79）μg·L-1,tmax（3.79±0.84）h,（3.63±0.74）h and（4.01±0.67）h,t1/2（8.26±1.78）h,（8.33±1.82）h and（8.36±1.31）h,AUC0-48（881.79±268.24）μg·L-1,（854.88±303.46）μg·L-1 and（835.85±272.76）μg·L-1,AUC0-∞（897.10±271.52）μg·L-1,（869.59±305.87）μg·L-1 and（851.77±278.86）μg·L-1respectively.The results of statistical analysis demonstrated the bioequivalence of reference and test preparations,and the relative mean bioavailability of two test preparations were（110.16±31.65）%and（104.75±23.42）% respectively.CONCLUSION The candesartan cilexetil tablets manufactured in China are bioequivalent to reference tablets.
Keywords：

candesartan; bioequivalence; pharmacokinetics; LC-MS/MS;

  • DOI：

    10.13286/j.cnki.chinhosppharmacyj.2014.19.08

  • Series：

  • Subject：

  • Classification Code：

    R969.1

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