Chronic Hepatitis B
Conditions
Interventions
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects aged 18 years or above; 2. The body mass index is within the range of 19.0~26.0 kg/m2 (including the critical value), with a male weight of no less than 50 kg and a female weight of no less than 45 kg; 3. Screening within two weeks before the test, and the results of vital sign assessment, physical examination, blood routine test, urine routine test, blood biochemistry, blood coagulation function, infectious disease screening, pregnancy test (female), 12 lead ECG and other tests judged by the research doctor to be normal or abnormal without clinical significance; 4. Have not had sexual intercourse without effective contraceptive measures within 30 days before screening, and agree to have no family planning within 3 months after screening and voluntarily adopt effective contraceptive measures as specified in the plan. Please refer to Appendix 4 for contraceptive measures; 5. The subjects fully understand the purpose, nature, method, and potential adverse reactions of the experiment, voluntarily act as subjects, and sign an informed consent form; 6. Those who can complete the experiment according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals who are allergic to any component of propofol tenofovir fumarate tablets or allergic individuals (such as those who are allergic to two or more drugs, food, and pollen); 2. Lactose intolerant individuals; 3. Patients with difficulty in venous blood collection or needle or blood sickness; 4. Those who have had a history of drug abuse within 5 years before screening, have used drugs or tested positive for drugs within 3 months before the trial; 5. Those who smoke more than 5 cigarettes per day or habitually use nicotine containing products or do not agree to stop smoking throughout the entire trial period within the first 3 months of screening; 6. Those who consume more than 14 units of alcohol per week (1 unit of alcohol=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the 6 months prior to screening, have taken alcoholic products 2 days prior to medication, have tested positive for alcohol, or do not agree to stop drinking throughout the entire trial period; 7. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before screening (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - ketoconazole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotic, verapamil, fluoroquinolones, antihistamines); 8. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or vitamins within 14 days before the start of the trial; 9. Those who have taken food or beverages containing enzymes that can induce or inhibit liver metabolism (such as grapefruit) within 7 days before the start of the experiment, or who do not agree to stop consuming these foods or beverages throughout the entire experiment period; 10. Those who consume any food or beverage containing or metabolizing caffeine or containing xanthine (such as coffee, tea, chocolate) within 48 hours before the start of the experiment, or do not agree to stop consuming these foods or beverages throughout the entire experiment period; 11. Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system (such as headache, dizziness), cardiovascular system, kidney (such as renal insufficiency), liver (such as liver insufficiency or bile stasis), gastrointestinal tract (such as swallowing difficulties, gastrointestinal ulcers, gastrointestinal disorders), respiratory system, metabolic, skeletal system diseases, or other factors that may affect the absorption, distribution, metabolism, and excretion of drugs; 12. Individuals with a history of joint pain; 13. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the trial, and those who have undergone surgery that will affect absorption, distribution, metabolism, and excretion; 14. People with positive antibodies to AIDS virus, hepatitis B virus surface antigen, hepatitis C virus and treponema pallidum; 15. Female subjects who have tested positive for pregnancy or are breastfeeding; 16. Those who have participated in other drug clinical trials within 3 months prior to screening; 17. Those who have a history of blood donation or have lost more than 400 mL of blood three months prior to screening; 18. Those who have special dietary requirements and cannot comply with unified dietary arrangements; 19. Other situations that the researcher deems unsuitable for participation in th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;AUC_%Extrap;?z; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed