Title: Study of the Bioequivalence of Trimetazidine Hydrochloride Tablets in Chinese Healthy Volunteers
Abstract: OBJECTIVE To study the relative bioavailability and bioequivalence of Trimetazidine Hydrochloride Tablets in healthy volunteers.METHODS A single oral dose(40 mg of tested and reference formulation)was given to 20 healthy volunteers in a randomised crossover study.The concentrations of Trimetazidine in plasma were determined by HPLC.The pharmacokinetic parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS program.RESULTS After a single dose,the pharmacokinetic parameters for Trimetazidine were as follows:ρmax were(122.78±11.60)and(115.12±10.98)μg·L-1;tmax were(2.08±0.34)and(2.13±0.39)h;AUC0-24 were(962.56±122.03)and(914.53±86.16)μg·h·L-1;AUC0-inf were(1 004.71±125.94)and(966.40±99.53)μg·h·L-1 for tested and reference formulation,respectively.The 90% confidential interval of AUC0-24,AUC0-inf and ρmax of tested formulation were 100.4%~109.5%,99.1%~108.4% and 102.6%~110.8%,respectively.CONCLUSION The relative bioavailability is(105.41±11.22)%.The results of the statistic analysis show that the two formulations are bioequivalent.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
Access and Citation
Cited By Count: 1
AI Researcher Chatbot
Get quick answers to your questions about the article from our AI researcher chatbot