Pharmacokinetics of single dose of Picika oral solution in Chinese healthy volunteers
10.13699/j.cnki.1001-6821.2016.03.012
- VernacularTitle:谱圣康口服液单次给药在中国健康人体药代动力学研究
- Author:
Zhen-Zhen ZHU
1
;
Feng DUAN
;
Jing-Feng BI
;
Zhen CHEN
;
Min WANG
;
Li ZHANG
;
Hui JI
;
Li-Wei LANG
;
Ben-Chao CHEN
;
Zhen-Man WEI
Author Information
1. 中国人民解放军第302 医院 新药临床试验中心
- Keywords:
Picika oral solution;
single dose;
pharmacokinetic;
plasma concentration;
urine concentration
- From:
The Chinese Journal of Clinical Pharmacology
2016;(3):230-234
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the pharmacokinetic changes of Picika oral solution in healthy subjects after single dose.Methods This study taken random , three cross experiment design , 12 subjects were randomly divided into 6 groups, each group was 2 cases, then they were respec-tively given single oral doseof Picika oral solution (60, 90, 120 mL) in each cycle.Before and after administration , biological samples were col-lected for detection of blood drug concentration and urine drug concentra-tion, furthermore, calculation of blood and urine drug pharmacokinetic parameters.Results After single oral dose of 60, 90, 120 mL Picika oral solution, the main pharmacokinetic parameters of plasma CKL -A03, Cmax were (3.08 ±0.92), (3.63 ±0.75), (4.29 ±1.00)μg· L-1, tmax were (57.50 ±17.90 ), (52.50 ±20.73 ), (56.25 ±19.32 ) min, t1/2 were (197.51 ±106.35 ), (233.86 ±196.75 ), (141.34 ±65.16 ) min, AUC0-t were ( 383.28 ± 86.42 ) , ( 479.00 ± 136.25 ) , (540.59 ±102.87)μg · L-1 · min, AUC0-∞ were (710.06 ±233.03 ), (916.59 ±378.62 ), (782.65 ±130.40 )μg· L-1 · min, respectively. The main pharmacokinetic parameters of urine CKL -A03, t1/2 were (1.29 ±0.33), (1.23 ±0.20), (1.11 ±0.11) h, total urine discharge rates were (0.28 ±0.22)%, (0.20 ±0.11)%, (0.18 ±0.09)%, urine discharge amount were (74486.02 ±57923.42 ), (80015.14 ±43379.01 ), (93017.33 ±46658.61 ) mg.Conclusion The maximum oral absorption amount of Picika oral solution is possible 90 mL.And there is no apparent proportional relationship between the total urine discharge rate , urine discharge amount and the increased doses.
