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)

First author:Zhou Ying

Corresponding author:Zhou Ying, Jiang Ji,Chen Xia

population pharmacodynamics population pharmacokin

essential_information

  • Person in charge:Zhou Ying
  • Data Sources: OTHERS
  • Number of papers:OTHERS20190811
  • Published time:2019-03-19

2019-03-19

Published articles

Journal:Frontiers in Pharmacology

Publication type: Correction

IF(IF): 5.81

PMID: 30941039 Link To Pubmed Full text Download

Background And Purpose

Method

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.

Conclusion

The model simulation will enable maintenance doses to be given more accurately for future study.

Main results