Pharmacokinetics of levosulpiride injection in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2015.05.011
- VernacularTitle:左舒必利注射液在中国健康受试者的药代动力学
- Author:
Ying ZHOU
1
;
Hu-Qun LI
;
Xiao-Meng HE
;
NI-Yang
;
Ming-Zhen XU
;
Wei-Yong LI
Author Information
1. 华中科技大学 同济医学院 附属协和医院 临床药理研究室
- Keywords:
levosulpiride;
HP-MS/MS;
single dose;
multiple dose;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2015;(5):354-357
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the pharmaeokinetics of single and multiple administration of levosulpiride in Chinese healthy volunteers.Methods An open, randomized and parallel study was conducted.Thirty subjects, half male half female, were divided into three groups and received single and multiple intramuscular injection of different doses of levosulpiride, respectively.Blood samples were collected at designed time and the concentrations of levosulpiride in plasma were determined by LC/MS/MS method.The pharmacokinetic parameters were calculated by DAS 3.0 software.Results The main pharmacokinetic parameters of single 25, 50 and 75 mg levosulpiride were as follows:cmaxwere (724.70 ±248.91), (949.60 ±234.80)and(1619.00 ±366.80)μg· L -1, t1/2 were (7.65 ±1.32 ) , ( 7.58 ±0.89 ) and ( 8.01 ±0.88 ) h, AUC0-t were ( 2874.17 ±1093.71 ) , ( 4481.75 ±913.09 ) and ( 7559.33 ± 1428.87) μg· L-1 · h, respectively.For the sequential administration, t1/2 was ( 7.41 ±0.79 ) h and AUC0-t was ( 4658.33 ±909.51 )μg· L-1 · h.Conclusion Single intramuscular injection of levo-sulpiride shows a good linear relationship between 25 and 75 mg in Chi-nese healthy volunteers.There is no accumulation tendency for the sequential administration found and there was no significant difference between male and female subjects.
