About this trial
The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1. Fully understand the content, process and possible adverse reactions of the trial before the trial, and be able to complete the study and sign the informed consent according to the requirements of the trial protocol;
Disqualifiers
1. (Inquiry) The subject has any of the following conditions: previous liver transplantation; Severe portal hypertension or transsurgical portosystemic shunt; Patients with suspected or confirmed liver cancer or other malignant tumors; Patients with hepatorenal syndrome; Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that seriously affect bile excretion; Patients with complications such as hepatic encephalopathy (according to Child-Pugh criteria), liver failure, esophageal and gastric varices bleeding, severe/advanced ascites or pleural effusion requiring puncture drainage and albumin supplementation, who were considered by the investigator to be unsuitable;
Trial design
Parallel
Treatments tested in this trial
Hemay005
Drug15mg/tablet,Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1
Treatment groups
Trial outcomes
Primary outcomes
Relevant pharmacokinetic parameters,Peak Plasma Concentration(Cmax)
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters,Area under the plasma concentration versus time curve(AUC0-t)
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters,Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters,half-life (T1/2)
All subjects who receive the drug will be analyzed for pharmacokinetic
Sponsors and contacts
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