Assessment on Bioequivalence of Tegaserod Maleate Dispersible Tablets in Human Body / 中国药房
China Pharmacy
; (12)2001.
Article
em Zh
| WPRIM
| ID: wpr-529026
Biblioteca responsável:
WPRO
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.
Texto completo:
1
Índice:
WPRIM
Tipo de estudo:
Clinical_trials
Idioma:
Zh
Revista:
China Pharmacy
Ano de publicação:
2001
Tipo de documento:
Article