Reflux esophagitis and duodenal ulcers
Conditions
Interventions
Moderate hepatic insufficiency group:A single dose of 20 mg of keplasen hydrochloride tablets in the fasting state
Normal liver function group:A single dose of 20 mg of keplasen hydrochloride tablets in the fasting state
Sponsors
Shulan (Quzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. subjects fully understands the purpose, content, process and possible adverse effects of the test, volunteer to be subjects and sign the informed consent form prior to the commencement of any trial procedure; 2. subjects (including partner) are willing to have no birth plan, no sperm or egg donation plan, and voluntarily use effective contraception from the time of signing the informed consent to 6 months after the last administration of the test drug; 3. subjects are able to communicate well with investigators and understand and comply with the requirements of the trial; 4. subjects are aged between 18 and 75 years (including borderline values); 5. weight =50kg for men and =45kg for women at screening; body mass index (BMI) within the range of 18.0-30.0 kg/m2 (including borderline values), BMI = weight (kg)/height2 (m2); 6. subjects with normal liver function must also meet the following inclusion criteria: normal results or abnormal but not clinically significant in the judgment of investigators after all examinations (including vital signs, physical examination, blood routine, urine routine, blood biochemistry, four items of coagulation function, 12-lead electrocardiogram, orthopantomogram of the chest, ultrasound of the abdomen, etc.) at screening; 7. subjects with hepatic insufficiency must also meet the following enrollment criteria: 1) albumin has not been used within 14 days prior to screening; 2) hepatic insufficiency due to viral hepatitis B, viral hepatitis C, alcoholic liver disease, autoimmune liver disease, non-alcoholic fatty liver disease, and inherited metabolic liver disease (except in patients with pharmacologic liver injury), with a Child-Pugh classification of class B; 3) stable (=1 month) hepatic insufficiency diagnosed by past medical history, laboratory tests or imaging; 4) in addition to the diseases and complications diagnosed as hepatic insufficiency, the results of the screening tests (including vital signs, physical examination, blood, urine, blood biochemistry, coagulation function, 12-lead electrocardiogram, chest X-ray, abdominal ultrasound, etc.), which are judged by the investigator to be in good physical condition with no other clinically significant abnormalities.
Exclusion criteria
Exclusion criteria: 1. subjects have a history of allergy to keplasen or any of the test drug components, or are hypersensitive (multiple drug and food allergies), or have a history of atopic allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.); 2. subjects have a malignant tumor at screening or a history of malignancy within 5 years prior to screening (except for hepatocellular carcinoma 2 years after cure and stabilization, non-melanoma of the skin for which treatment has been administered and there are no signs of recurrence, and resected cervical intraepithelial neoplasia); 3. the subject has abused drugs at the current stage; or has abused drugs in the past; or has used soft drugs (e.g., marijuana) in the 3 months prior to administration of the test drug or has used hard drugs (e.g., cocaine, amphetamines, phenylcyclohexylpiperidines, etc.) in the 1 year prior to administration of the test drug; 4. the subject is addicted to tobacco at the current stage; or was previously addicted to tobacco; or averaged more than 5 cigarettes per day in the 3 months prior to screening; or was unable to stop ingesting any tobacco-based products during the trial; 5. the subject is a current heavy drinker; or a former heavy drinker; or a regular drinker (regular drinker is defined as an average of more than 14 units of alcohol per week for females and more than 28 units of alcohol per week for males, e.g., 1 unit = 360mL of beer or 45mL of 40% alcohol by volume spirits, or 150mL of wine) in the month prior to Screening; or is unable to stop consuming alcohol during the trial; 6. the subject has donated blood (including component blood) or lost a significant amount of blood (=400mL), or received a blood transfusion or used blood products within 3 months prior to screening; 7. the subject has had a serious infection, trauma, gastrointestinal surgery, or other major surgical procedure within 4 weeks prior to Screening; 8. the subject is undergoing surgical treatment or is predisposed to hospitalization during the planned trial period; 9. the subject has participated in another clinical trial and received the test drug within 3 months or 5 half-lives of the test drug, whichever is longer, prior to Screening; 10. the subject has received a vaccine within 1 month prior to Screening; 11. subjects have used herbs or strong inhibitors or strong inducers of CYP450 enzymes within 4 weeks prior to administration of the test drug; 12. subjects who have taken any medication within 14 days (or 5 half-lives, whichever is longer) prior to taking the test drug, including prescription medications, over-the-counter medications, herbal medications, or health supplements such as vitamins, with the exception of stabilizing medications for patients with hepatic insufficiency; 13. subjects taking test drugs with special dietary requirements, who cannot accept a uniform diet during the trial, or who have difficulty swallowing; 14. subjects can not tolerate venipuncture or needle-sickness, blood-sickness; 15. female subjects are pregnant or breastfeeding; 16. female subjects have a positive blood pregnancy test; 17. subjects' syphilis spirochete-specific antibody test, which were clinically significant; 18. subjects' combined human immunodeficiency virus (HIV) antigen-antibody test are clinically significant; 19. subjects who have ingested any special diet within 48 hours prior to adm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators; | — |
Countries
China
Contacts
Public ContactGuiling Chen/Xiahong Dai
Shulan (Quzhou) Hospital
Outcome results
None listed