Title: Study on bioequivalence of irbesartan tablets produced by two companies
Abstract: AIM:To study the pharmacokinetics and relative bioavailability of irbesartan tablets.METHODS:A single oral dose of 300 mg irbesartan of reference or test tablet was given to each of 18 male healthy volunteers according to an open randomized crossover design.The concentrations of irbesartan in plasma were determined by HPLC.RESULTS:The main pharmacokinetic parameters of irbesartan showed that Cmax were(3147±922) and(2856±652) ng/mL,tmax were(1.6±0.7) and(1.9±1.1) h,AUC0→t were(17559±7482) and(17366±5498) ng·mL-1·h,AUC0→∞ were(18276±7710) and(18284±5336) ng·mL-1·h for reference or test tablet respectively.There was no significant difference between the parameters of two tablets.CONCLUSION:The relative bioavailability of test tablet to reference tablet is 101%±32%.The results of statistical analysis show that two formulations are bioequivalent.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
Access and Citation
AI Researcher Chatbot
Get quick answers to your questions about the article from our AI researcher chatbot