Title: Pharmacokinetics and bioequivalence of domestic and imported amisulpride tablets in healthy volunteers
Abstract: Objective To evaluate the bioequivalence of domestic amisulpride tablets and imported tablets.Methods A single oral dose of 200 mg domestic and imported amisulpride tablets were given to twenty healthy volunteers in a randomized crossover study.4 mL blood was collected at scheduled time.The concentrations of amisulpride were determined by HPLC-MS/MS method.Results The main pharmacokinetic parameters of two preparations were as follows: AUC0-48 were(3.01±0.86),(2.94±0.88) μg·h·mL-1,Cmax were(392.19±135.35),(419.84±154.25) ng·mL-1,t1/2 were(9.42±3.02),(8.89±3.05) h,tmax were(3.70±0.80),(3.80±0.77) h,respectively.The relative bioavailability of domestic and imported amisulpride tablet to imported tablet was(104.0±17.1)%.Conclution The results demonstrated that the two preparations were bioequivalent.
Publication Year: 2010
Publication Date: 2010-01-01
Language: en
Type: article
Access and Citation
AI Researcher Chatbot
Get quick answers to your questions about the article from our AI researcher chatbot