HIV/ADIS
Conditions
Interventions
Group T-R:Tablet
it is orally administered on an empty stomach, 1 tablet per cycle, 2 cycles in total.
Group R-T:Tablet
Specification: ACC007 2 tablets + lamivudine 1 tablet + tenofovir fumarate 1 tablet
oral administration on an empty stomach, 2 tablets per cycle, 2 cycles in total.
Sponsors
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-65 years; 2. The body weight of male subjects >=50.0 kg, female subjects >=45.0 kg, body mass index (BMI) within the range of 18.0-28.0 kg/m2 (including the threshold, BMI = body weight (kg)/height 2 (M2)); 3. Vital signs: systolic pressure 90-140mmhg, diastolic pressure 50-90mmhg, pulse 50-100 times / min, body temperature (ear temperature) 35.9-37.6 degree C, including the threshold; 4. Subjects have no birth plans, sperm or egg donation plans, or voluntarily adopt effective physical contraception within 6 months after the last dose; 5. Before the trial, the subjects had a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential danger of the trial, and voluntarily participated in the clinical trial, could communicate well with the researchers, complied with the requirements of the whole study, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have allergic history to acc007, lamivudine, tenofovir fumarate or any drug component, or have specific allergic history (asthma, urticaria, eczema, etc.), or have allergic constitution (such as those who are allergic to two or more drugs, food or pollen); 2. Those have suffered from or are suffering from any serious clinical diseases, such as digestive system, cardiovascular system, endocrine system, nervous system or respiratory system, hematology, immunology, psychiatric diseases and metabolic abnormalities, which have affected the study according to the judgment of the researcher; 3. Those with the results of laboratory examination (blood routine, urine routine, blood biochemistry, blood coagulation function), physical examination and ECG were judged as abnormal by the clinician; 4. Those who have undergone surgery within 3 months before administration or plan to have surgery during the study period; 5. Patients with renal insufficiency, gastrointestinal dysfunction, or previous history of digestive tract disease or operation that has affected the absorption of the drug; 6. Those have taken any drug that changes the activity of liver enzyme was used within 28 days before screening, or the following CYP3A4, CYP2C19, P-gp or BCRP inhibitors or inducers were used, such as itraconazole, ketoconazole or dronedarone; 7. Those with hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or HIV positive; 8. Pregnant or lactating women, or positive pregnancy screening (women); 9. Those who have taken any medicine (including Chinese herbal medicine) within 14 days before administration; 10. Those with blood loss or donation of more than 400 ml within 1 month before the test, or blood donation planned during the test or within 1 month after the end of the test; 11. Smokers or those who smoke more than 5 cigarettes per day on average in the three months before screening, or those who do not agree to avoid using any tobacco products during the trial period; 12. Alcoholics or regular drinkers within 6 months before screening, i.e. those who drink more than 14 units of alcohol per week on average (1 unit = 360 ml of beer or 45 ml of spirits or 150 ml of wine with 40% alcohol content), or who can't stop drinking during the test; 13. Those who have taken special diet (including grapefruit / grapefruit juice, chocolate, xanthine containing diet, caffeinated food or beverage, etc.) and / or excessive tea, coffee and / or caffeinated beverage (average more than 8 cups per day, 200ml per cup) within 3 days before administration; 14. Those who have used any drugs within one year before administration; 15. Those have taken any clinical trial drug within 3 months before administration; 16. Those who are positive in alcohol breath test; 17. Those with positive urine drug screening; 18. Those who have difficulty of venous blood collection or intolerability of venipuncture; 19. Those who have difficulty of swallowing, or having special requirements for diet, and being unable to follow the unified diet; 20. Those who are judged by the researchers that there was a lower possibility of enrollment (including the inability to understand the research requirements, poor compliance, weakness, etc.) or other factors that the researcher thought were not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactJuan Li
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed