Pharmacokinetics and bioequivalence of domestic and imported amisulpride tablets in healthy volunteers
10.3969/j.issn.1001-6821.2010.01.009
- VernacularTitle:国产与进口氨磺必利片在健康人体的药代动力学和生物等效性
- Author:
Xian LI
1
;
Gui-Yan YUAN
;
Ben-Jie WANG
;
Rui-Chen GUO
Author Information
1. 山东大学齐鲁医院
- Keywords:
amisulpride;
bioequivalence;
pharmacokineties;
LC-MS/MS
- From:
The Chinese Journal of Clinical Pharmacology
2010;26(1):33-36
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the bioequivalence of domestic amisulpride hablets 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 col-lected at scheduled time.The concentrations of amisulpride were deter-mined bv HPLC-MS/MS method.Resuits The main pharmacokinetic parameters of two preparations were as follows:AUC_(0-48) were(3.01±0.86),(2.94±0.88)μg·h·mL~(-1),C_(max) were(392.19±135.35),(419.84±154.25)ng·mL~(-1),t_(1/2) were(9.42±3.02),(8.89±3.05)h,t_(max) were(3.70±0.80),(3.80±0.77)h,respectively.The relative bioavailability of domestic and imported amisulpride tablet to im-ported tablet was(104.0±17.1)%.Conclution The results demon-strated that the two preparations were bioequivalent.
