Pharmacokinetics of armodafinil tablets in Chinese healthy volunteers
10.13699/j.cnki.1001-6821.2017.14.010
- VernacularTitle:阿莫达非尼片在健康受试者体内的药代动力学研究
- Author:
Li ZHANG
1
;
Li-Wei LANG
;
Zhen-Zhen ZHU
;
Zhen CHEN
;
Feng DUAN
;
Zhen-Man WEI
Author Information
1. 中国人民解放军第三○二医院药物临床试验中心
- Keywords:
armodafinil;
LC-MS/MS;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(14):1321-1323
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the single dose oral administration of armodafinil in Chinese healthy volunteers.Methods This was a single center,opened,randomized,three-way crossover study.Twelve healthy Chinese volunteers received armodafinil 100,200,400 mg,oral administration,respectively.The plasma concentrations were determined by LC-MS/MS.Pharmacokinetic parameters were obtained using DAS 2.1.1 program.Results The main pharmacokinetic parameters of armodafinil of 100,200,400 mg dose groups were as follows:t1/2 were (11.96 ± 1.37),(12.66 ± 1.56),(13.13 ± 1.05) h,tmax were (2.41 ±1.43),(2.50 ± 1.28),(3.00 ± 1.37) h,Cmax were (3117 ±715.8),(5952 ± 1183),(11522 ± 2821) μg · L-1.AUC0-t were (535.49±126.21) ×102,(1081.53 ±241.91) ×102,(2268.71 ±564.30) × 102 h μg L-1,AUC0-∞ were (553.66 ± 124.27) × 102,(1105.26±250.90) × 102,(2293.59 ±565.52) × 102 h · μg · L-1.Conclusion Armodafinil 100,200,400 mg were safe in Chinese healthy volunteers.
