Pharmacokinetics and bioequivalence of two pantoprazole sodium enteric-coated tablet products in healthy Chinese volunteers

作     者：徐海燕 张鹏 王学娅 申涛 赵怀清 Hai-Yan Xu;Peng Zhang;Xue-Ya Wang;Tao Shen;Huai-Qing Zhao

作者机构：沈阳药科大学药学院沈阳110016 辽宁中医药大学职业技术学院沈阳110101 

出 版 物：《Journal of Chinese Pharmaceutical Sciences》 (中国药学（英文版）)

年 卷 期：2007年第16卷第3期

页      码：170-175页

摘      要：Aim To evaluate the pharmacokinetics and bioequivalence of domestic pantoprazole sodium enteric-coated tablets as compared with imported pantoprazole enteric-coated tablets. Methods This was an open randomized, two periods cross over study on twenty healthy male volunteers. The pantoprazole concentrations in plasma after an oral dose of 40 mg pantoprzaole preparations were determined by a HPLC-UV method. Non-compartmental method was used for the calculation of pharmacokinetic parameters. Logarithm-transformed Cmax and A UC were analyzed by the analysis of variance （ANOVA） with 90% confidence intervals. Results The main pharmacokinetics parameters of domestic pantoprazole sodium enteric-coated tablets and imported pantoprazole sodium enteric-coated tablets were as following： Cmax （3610 ± 956）, （3466 ± 1209） ng·mL^-1, tmax （3.00 ± 0.40）, （3.00 ± 0.46） h, AUC0-t （8140 ± 5065）, （8390 ± 5474） ng·h·mL^-1, AUC0-∞ （8293 ± 5094）, （8625 ± 5606） ng·h·mL^-1, t1/2 （1.61 ± 0.28）, （1.85 ± 0.27） h, respectively. Conclusion Domestic pantoprazole sodium enteric-coated tablets were bioequivalent with the imported pantoprazole sodium enteric-coated tablets.

主 题 词：Pantoprazole HPLC-UV Pharmacokinetics Bioequivalence 

学科分类：1007[医学-药学类] 1006[医学-中西医结合类] 100706[100706] 100602[100602] 10[医学] 

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