中国临床药理学与治疗学2005，Vol.10Issue(11)：1236-1239,4.
泮托拉唑钠肠溶片在中国男性健康志愿者体内的药动学和相对生物利用度研究
Pharmacokinetics and relative bioavailability of pantoprazole sodium enteric-coated tablets in healthy male Chinese volunteers
师少军 1李忠芳 2陈华庭 1曾繁典3
作者信息
- 1. 华中科技大学同济医学院附属协和医院药剂科,武汉,430022,湖北
- 2. 华中科技大学同济医学院附属协和医院妇产科,武汉,430022,湖北
- 3. 同济医学院临床药理研究所,武汉,430030,湖北
- 折叠
摘要
Abstract
AIM: To study pharmacokinetics and relative bioavailability of pantoprazole sodium enteric-coated test and reference tablets in healthy volunteers. METHODS: A single oral dose of 40 mg pantoprazole sodium enteric-coated test and reference tablets were given to 20 male healthy volunteers in a randomized two-way crossover design. Plasma concentrations of pantoprazole were determined by HPLC method. Pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations. RESULTS: Plasma concentration-time profiles were adequately described by a two-compartment open model. The main pharmacokinetic parameters of pantoprazole sodium test and reference tablets were as follow: The values of Tmax were (3.18±0.54) and (3.30±0.47) h, Cmax were (2.98±0.83) and (2.91±0.87) mg·L-1, T1/2β were (1.86±0.41) and (1.72±0.48) h, AUC0-t were (9.51±3.71) and (9.77±4.55) mg·h·L-1, respectively. The relative bioavailability of test tablets was (102.3±19.6)%. CONCLUSION: The two preparations of pantoprazole sodium are bioequivalent.关键词
泮托拉唑钠肠溶片/高效液相色谱法/药代动力学/生物利用度Key words
pantoprazole sodium enteric-coated tablets/HPLC/pharmacokinetics/bioavailability分类
医药卫生引用本文复制引用
师少军,李忠芳,陈华庭,曾繁典..泮托拉唑钠肠溶片在中国男性健康志愿者体内的药动学和相对生物利用度研究[J].中国临床药理学与治疗学,2005,10(11):1236-1239,4.
