Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT04305392
Eligibility Criteria:
Inclusion Criteria:
\-
All subjects:
* Signing the informed consent forms.
* 18 years to 65 years (inclusive).
* Body mass index should be between 18 and 30 kg/m2 (inclusive).
* No medication was used before screening#or stable medication for 4 weeks.
Normal liver function:
• Clinical laboratory tests during the screening period were normal or the abnormality has no clinical significance.
Hepatic impaired subjects:
* Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
* Liver damage due to primary liver disease.
Exclusion Criteria:
\-
All subjects:
• Subject known or suspected of being sensitive to the study drugs or its ingredient.
Normal liver function:
* Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
* Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.
Hepatic impaired subjects:
* Suspected or diagnosed as liver cancer or with other malignant tumors.
* Drug induced liver injury#acute liver injury#liver transplantation history.
* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04305392
Study Brief:
Protocol Section:
NCT04305392