Title: Bioavailability and Bioequivalence Study of Levofloxacin Tablets in Chinese Healthy Volunteers
Abstract: OBJECTIVE The aim is to study the relative bioavailability of levofloxacin tablet in Chinese healthy volunteers and to evaluate the bioequivalence.METHODS A single oral dose 200mg of test and reference formulations was given to 20 healthy volunteers in a randomized cross-over study.The concentrations of levofloxacin in plasma were determined by HPLC.RESULTS The main pharmacokinetic parameters of two formulations,test and reference,were as follows: t1/2 were(11.0±3.2)h and(9.5±2.6)h;Tmax were(0.90±0.46)h and(1.3±0.62)h;Cmax were(2.7±0.75)μg·mL-1 and(2.65±0.70)μg·mL-1;AUC0-T were(16.6±3.0)μg·h·mL-1 and(16.5±2.6)μg·h·mL-1;AUC0-∞ were(18.2±3.9)μg·h·mL-1 and(18.9±3.2)μg·h·mL-1,respectively.The relative bioavailability of AUC0-T was(100.6±10.2)%.The results of ANOVA and two one-sided t test statistical analysis for In Cmax,In AUC0-T and In AUC0-∞ showed that two formulations were bioequivalent.The 90% confidence interval of AUC0-T and AUC0-∞ were 100.3%~113.0% and 100.1%~112.2%,in the range of 80~125%;Cmax was 95.0%~115.4%,also in the range of 70%~143%,so the two tablets were bioequivalent.CONCLUSION The test and reference levofloxacin tablets were bioequivalent.
Publication Year: 2008
Publication Date: 2008-01-01
Language: en
Type: article
Access and Citation
AI Researcher Chatbot
Get quick answers to your questions about the article from our AI researcher chatbot