Actively Recruiting
To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage
Led by Ganzhou Hemay Pharmaceutical Co., Ltd · Updated on 2025-12-04
24
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and sign informed consent
- Adults aged 18 to 70 years
- Male body weight at least 50 kg; female body weight at least 45 kg
- Body mass index between 19 and 32 kg/m2
- Have chronic stable mild or moderate liver impairment due to primary liver disease
- Stable medication plan for liver impairment and related conditions for at least 28 days (14 days for moderate impairment) or no medication
- Good physical condition aside from liver impairment as assessed by medical history and tests
You will not qualify if you...
- History of liver transplantation, severe portal hypertension, or transsurgical portosystemic shunt
- Suspected or confirmed liver cancer or other malignant tumors
- Hepatorenal syndrome or other serious bile excretion diseases
- Severe liver complications such as encephalopathy, liver failure, variceal bleeding, advanced ascites or pleural effusion
- Serious acute or chronic diseases of other major organs within 1 year
- Cardiac events or conditions within 6 months prior to study
- History of depression or suicidal tendencies
- Severe gastrointestinal diseases or recent digestive surgery
- Recent significant blood loss or transfusion
- Active liver function fluctuation or rapid deterioration
- Abnormal lab tests including high ALT, low neutrophils, low hemoglobin, low platelets, or high AFP
- Allergies to PDE4 inhibitors or multiple allergies
- History of drug abuse within past 3 to 5 years or positive drug abuse screen
- Positive breath alcohol test or high alcohol consumption
- Smoking more than 5 cigarettes per day or inability to stop tobacco use
- Excessive caffeine or tea/coffee intake
- Clinically significant positive tests for hepatitis B, C, HIV, or syphilis
- Participation in other clinical trials within 3 months
- Use of hepatotoxic drugs for 7 or more consecutive days within 3 months
- Use of drugs affecting liver enzymes within 30 days
- Use of other drugs, supplements, or vaccines within 2 weeks except for liver or concomitant disease treatment
- Consumption of caffeine/xanthine-rich foods or drinks that affect drug metabolism
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Inability to eat, swallow, or follow diet requirements
- History of epileptic seizures
- Inability to tolerate venipuncture or history of dizziness with blood draws
- Other factors judged by investigator as making participant ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital of Tongji Medical College; Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
Z
Zimeng Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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