国家神经系统疾病临床医学研究中心数据管理与共享系统
Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases
Population Pharmacokinetic/Pharmacodynamic Model-Guided Dosing Optimization of a Novel Sedative HR7056 in Chinese Healthy Subjects (vol 9, 1316, 2018)
第一作者：Zhou Ying
2019-03-19
已发表文章
主要研究背景及目的
方法
We report on modeling of the data and simulations of dosage regimens for future study. Up to 63 subjects were evaluated, using Bispectral Index (BIS) and Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) as pharmacodynamics endpoints. A three-compartment model best described HR7056 pharmacokinetics. Total clearance was 1.49 L min−1, central volume was 2.1 L, inter-compartmental clearances were 0.96 and 0.27 L min−1, respectively. The population mean pharmacodynamic parameters were as follows: BIS, E0: 95.3; IC50: 503 ng mL−1; γ: 1.5; ke0: 0.0855 min−1; Imax: 47.9 and MOAA/S, IC50: 436 ng mL−1; γ: 1.5; ke0: 0.05 min−1; Imax: 27.9.
结论
The model simulation will enable maintenance doses to be given more accurately for future study.