机构：[1]GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[2]Tasly Academy, Tasly Holding Group Co. Ltd., Tianjin, China[3]Phase I Unit, Clinical Pharmacology Research Center, Peking Union Medical College Hospital & Chinese Academy of Medical Sciences, Beijing, China
Ginsenoside H dripping pill (GH) is a novel clinical-stage adjuvant for the treatment of non-small cell lung cancer. In this study, the pharmacokinetics of ginsenoside Rh2, the major anticancer ingredient of GH, was investigated in healthy volunteers. Enrolled volunteers were assigned to 3 cohorts-7.8, 15.6, and 31.2 mg-and received single and/or multiple GH orally. Blood samples were assayed by a validated bioanalytical method, and drug concentrations were analyzed using a noncompartmental methodology. The results showed that ginsenoside Rh2 was absorbed with medium speed and reached Cmax a median of 3 hours after administration. The exposure of ginsenoside Rh2 was approximately dose-dependent in terms of AUC and Cmax . The plasma concentration of ginsenoside Rh2 reached steady state after oral administration of GH twice daily for 5 days. There was no obvious accumulation in exposure parameters in the multiple-dose study.
基金：
This work was financially sponsored by Tasly Holding Group Co. Ltd. This research was supported by Major Specific Project of Sichuan Province of China (2020YFS0034), Youth Program of the National Natural Science Foundation of China (81903722), and the Ministry of Science and Technology of China Funds (2017ZX09304023).
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
大类|4 区医学
小类|4 区药学
最新[2023]版：
大类|4 区医学
小类|4 区药学
第一作者：
第一作者机构：[1]GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, China
通讯作者：
通讯机构：[1]GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, China[*1]GCP Center/Institute of Drug Clinical Trials, West China Hospital,Sichuan University,No.5 Gongxing Road,Wuhou District, Chengdu, 610041, China
推荐引用方式(GB/T 7714)：
ZhenleiWang,Rui Liu,Li Chen,et al.Pharmacokinetics of Ginsenoside Rh2, the Major Anticancer Ingredient of Ginsenoside H Dripping Pills, in Healthy Subjects.[J].Clinical pharmacology in drug development.2021,10(6):669-674.doi:10.1002/cpdd.877.
APA：
ZhenleiWang,Rui Liu,Li Chen,HuanhuanWang,Mi Zhou...&Yongping Qin.(2021).Pharmacokinetics of Ginsenoside Rh2, the Major Anticancer Ingredient of Ginsenoside H Dripping Pills, in Healthy Subjects..Clinical pharmacology in drug development,10,(6)
MLA：
ZhenleiWang,et al."Pharmacokinetics of Ginsenoside Rh2, the Major Anticancer Ingredient of Ginsenoside H Dripping Pills, in Healthy Subjects.".Clinical pharmacology in drug development 10..6(2021):669-674
