Effect of diet on the pharmacokinetic of Picika oral solution in healthy human
10.13699/j.cnki.1001-6821.2016.03.011
- VernacularTitle:饮食对谱圣康口服液在健康人体的药代动力学的研究
- Author:
Feng DUAN
1
;
Zhen-Zhen ZHU
;
Jing-Feng BI
;
Ben-Chao CHEN
;
Zhen CHEN
;
Li ZHANG
;
Hui JI
;
Li-Wei LANG
;
Min WANG
;
Zhen-Man WEI
Author Information
1. 中国人民解放军第三〇二医院 新药临床试验中心
- Keywords:
Picika oral solution;
diet test;
pharmacokinetic;
phase Ⅰclinical trial;
self-control
- From:
The Chinese Journal of Clinical Pharmacology
2016;(3):227-229
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the influence of diet on the pharmacoki-netic of Picika oral solution in healthy subjects.Methods This study taken random , before and after self-control design.Twelve subjects were randomly divided into 2 groups, each group was 6 cases, then they were given Picika oral solution 60 mL respectively before and after meal.Before and after administration , blood and urine samples were collected at different points , the plasma and urine concentration was measured and pharmacokinetic parameters were calculated.Results Before and after administration of Picika oral solution 60 mL, the drug pharmacokinetic parameters of active ingredients -CKL-A03 were listed as follows:t1/2 was ( 126.13 ± 74.04 ) , ( 104.81 ± 68.44 ) min; tmax were (53.75 ±10.03 ) and (58.75 ±11.89 ) min;Cmax were (3.06 ±0.86 ) and ( 3.81 ±2.82 )μg· L-1; AUC0-t were ( 268.81 ±84.25 ) and (355.03 ±177.82 )μg· L-1 · min in plasma respectively.t1/2 was (1.14 ± 0.12 ), ( 1.24 ± 0.16 ) h in the urine respectively.Conclusion Diet may affect the absorption and eliminate speed of the drug.
