Chronic adult hepatitis B
Conditions
Interventions
A:T-R
B:R-T
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers, aged >= 18 years; 2. There is no limit to gender, both men and women, and the proportion of single gender is not less than 1 / 4; 3. Body mass index is 19.0-26.0kg/m2 (including critical value), male body weight >= 50.0kg, female body weight >= 45.0kg; 4. The subject must give informed consent to the test before the test, and sign the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, especially for patients allergic to entecavir tablets, excipients and similar substances; 2. Patients with dysphagia or any disease that may affect the absorption of drugs in vivo; 3. Patients with any serious clinical disease history (circulatory, respiratory, digestive, urinary, blood, nervous, endocrine and metabolic systems); 4. Patients who cannot communicate or cooperate with medical staff due to nervous, mental illness or language disorders; 5. Patients with difficulty in venous blood collection, or objects with history of needle syncope and blood syncope; 6. Those who have consumed excessive tea, coffee or caffeinated drinks for a long time (more than 8 cups a day, 1 cup = 200ml); 7. The subjects who used to drink too much alcohol or who often drank alcohol within 6 months before the test (more than 14 units of alcohol per week, 1 unit = 360ml of beer or 45ml of spirits or 150ml of wine with 40% alcohol content) and the subjects who could not prohibit alcohol during the whole test period; 8. Objects with a history of drug abuse / dependence or drug history within one year before the first drug use; 9. Patients who had used hormone replacement therapy (except hormone contraceptives) within 3 months before the first use of the drug; 10. Subjects who have participated in any drug clinical trial and taken the test drug within 3 months before the first drug use; 11. Those who smoked more than 5 cigarettes per day in the three months before the first use of the drug and those who could not be banned during the whole test period; 12. Subjects who donate blood or lose blood >= 200ml within 3 months before the first medication, or who plan to donate blood or blood components within 3 months after the end of the trial or during the trial; 13. Patients who had surgery within 3 months before the first medication; 14. Patients who use any known liver enzyme inducer or liver enzyme inhibitor within 30 days before the first application; 15. Objects who have used any medicine (including prescription medicine, over-the-counter medicine, Chinese herbal medicine, etc.) or health products within 14 days before the first use of medicine; 16. Those who cannot follow the unified diet; 17. Pregnant or lactating women, or men or women who have pregnancy plans or are unwilling to take barrier contraceptive measures from the whole trial period to 1 month after the end of the trial, and women who have not taken barrier contraceptive measures within 2 weeks before the first medication; 18. Subjects with abnormal results of physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry, amylase, coagulation function, etc.) and 12 lead ECG, which have clinical significance and influence on the evaluation of this trial; 19. Patients with abnormal and clinically significant results determined by the researchers according to the test results of hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antibody; 20. Patients with abnormal alcohol breath test (acceptable range: 0-3mg / 100ml); 21. Patients with positive drug abuse test; 22. Subjects were to take any food containing caffeine (such as coffee, tea, chocolate, etc.), alcohol, grapefruit (grapefruit juice, lemon, orange juice, etc.), or foods rich in xanthine (sardine, bovine liver, etc.) within 48 hours before the first use. 23. The subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
china
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed