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Clinical Trial Summary

The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in mild and moderate hepatic impaired subjects and matched healthy adult subjects.


Clinical Trial Description

This is an open-label and paralleled study with single oral dose of HMS5552 given to hepatic impaired subjects and matched healthy volunteers. The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in hepatic impaired subjects and (gender, age and BMI) matched healthy adult subjects. The secondary objective is to characterize the safety profiles of HMS5552 in single dose in hepatic impaired subjects. The subjects include mild hepatic impaired subjects (A group), moderate hepatic impaired subjects (B group), and healthy subjects (C Group) matched with hepatic impaired subjects in gender, age and BMI. The number of subjects in each group was no less than 8, and no less than 3 subjects in each gender. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04426708
Study type Interventional
Source Hua Medicine Limited
Contact
Status Completed
Phase Phase 1
Start date February 18, 2019
Completion date July 3, 2020

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