To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage

ConditionPsoriasis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGanzhou Hemay Pharmaceutical Co., Ltd

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hemay005

    Drug

    15mg/tablet,Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Mild liver damage groupExperimental treatment 1 intervention
Group B: Moderate liver damage groupExperimental treatment 1 intervention
Group C: Healthy subjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relevant pharmacokinetic parameters,Peak Plasma Concentration(Cmax)

All subjects who receive the drug will be analyzed for pharmacokinetic

Time frame
Day1-Day6
2

Relevant pharmacokinetic parameters,Area under the plasma concentration versus time curve(AUC0-t)

All subjects who receive the drug will be analyzed for pharmacokinetic

Time frame
Day1-Day6
3

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

Time frame
Day1-Day6
4

Relevant pharmacokinetic parameters,half-life (T1/2)

All subjects who receive the drug will be analyzed for pharmacokinetic

Time frame
Day1-Day6

Secondary outcomes

Other outcomes

Sponsors and contacts

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