Assessment on Bioequivalence of Tegaserod Maleate Dispersible Tablets in Human Body
- VernacularTitle:马来酸替加色罗分散片的人体生物等效性研究
- Author:
Aidong WEN
;
Linlin BI
;
Yanyan JIA
;
Min ZHOU
;
Yin WU
;
Zhirui WANG
- Publication Type:Journal Article
- Keywords:
Tegaserod maleate dispersible tablet;
LC/MS/MS;
Bioequivalence
- From:
China Pharmacy
2001;0(08):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To study the bioequivalence of tegaserod maleate dispersible tablets in healthy volunteers.METHODS: A single oral dose of 6mg test or reference preparations of tegaserod maleate was given to 22 healthy volunteers in a randomized crossover study.The plasma concentrations of tegaserod were determined by LC/MS/MS assay.RESULTS: The main pharmacokinetic parameters of test and reference products were as follows: tmax(0.86? 0.22) and(1. 01? 0.24) h;Cmax(2.21? 0.69) and(2.05? 0.64) ng? mL1;AUC0～ 17(6.35? 2.48) and(6.47? 1.99) ng? h? mL-1,AUC0～ ∞(6.69? 2.59) and(6.70? 2.03) ng? h? mL-1,respectively.The relative bioavailability of test to reference preparation was(98.2? 22.1) %.CONCLUSION: The reference preparation and the test preparation are bioequivalent.
