Non-nucleoside reverse transcriptase inhibitors,and other antiretroviral drugs in combination with HIV/AIDS
Conditions
Interventions
75mg:300mg once a day oral administration of ACC007 tablets with 75mg specification, subjects in Group A are oral administrated with (3TC 300mg+TDF 300mg) from Day1 to Day17, and with the addition of
75mg:300mg once a day oral administration of ACC007 tablets with 75mg specification, subjects in Group B are oral administrated with 300mg ACC007 from Day1 to Day17, and with the addition of (3TC 300m
Sponsors
Beijing Di Tan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subjects should fully understand the investigational nature, methods, and possible reactions of this study ,comply with the requirements listed in the informed consent and voluntarily signed informed consent. 2. Male or female between 18 to 50 years of age. 3. Subjects with body weight=45kg and body mass index(BMI)between 19 to 25kg/m2 BMI=weight(kg)/{height(m)}2. 4. No birth plan within six months. For females of child-bearing potential only; (1) Test negative for pregnancy at the time of screening; (2) Are sexually inactive at least 6 weeks or have practiced a reliable method of birth control(for example, use of oral contraceptives or levonorgestrel; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abatinence) for at least 6 weeks prior to screening. For males: Agree to continue to use a reliable method of birth control during the study. 5. Subjects pass the physical examination, vital signs examination, laboratory examination (blood routine, urine routine, liver function, renal function, blood glucose, etc.), 12-lead ECG examination, or mild abnormalities in the test but the researchers believe that there is no clinical significance.
Exclusion criteria
Exclusion criteria: 1. Subjects who smoke more than 5 cigarettes per day for the first 3 months of screening or cannot give up smoking during the entire study period; 2. Those who regularly drink alcohol within the first 6 months of screening, meaning more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or who cannot give up drinking during the study period, or positive in alcohol breath test; 3. Subjects whit history of drug abuse or a positive in urine screening test within 12 months prior to screening; 4. Subjects who have diseases of neuro/psychiatric system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal muscle system or any other diseases or physiological conditions that may affect the results of the study; 5. Subjects whose value of AST or ALT is greater than 1.5 times the upper limit of the reference range; 6. Subjects who are Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive, or RPR positive; 7. Subjects with history of gastrointestinal disease or surgery(except simple appendectomy or repair of hernia),which can influence the absorption of the study drug; 8. Subjects whit history of drug allergy (for the test drug or any other excipient) or People with allergies history 9. Subjects who have fever within three days; 10. Subjects who have taken any drugs that may affect the test results, such as metoxazole combo, within two weeks prior to enrollment; 11. Subjects who have taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, subjects who have taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration; 12. Those who have special dietary requirements may not comply with the provided diet and the corresponding regulations. During theclinical trial, they should use caffeine or jaundice drinks or food or certain fruits that may affect metabolism (ponado, mango, grapefruit, carambola, pomegranate, pineapple, grapefruit); 13. Subjects who have participated in any other clinical trial either for investigational or marketed grugs within 3 months before the study drug administration; 14. Subjects who have donated or had loss of = 400ml of blood within 3 moths prior to start of administration of study drug; 15. Female subjects who are pregnant or nursing; 16. Systolic blood pressure outside the range of 80 to 140mm Hg, or diastolic blood pressure outside the range of 60 to 85mm Hg, or heart rate outside the range of 50 to 100 beats per minute(bpm)for females; outside and the range of 45 to 100 beats per minute(bpm)for male subjects(Blood pressure and heart rate should be taken after 10 minutes of rest); 17. Subjects who cannot swallow test drugs according to the program requirements; 18. Subjects judged by the investigator that are not eligible for the study after reviewing clinical laboratory results or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerance Assessment:Adverse events,physical examinations,vital signs,electrocardiogram,and laboratory tests,Pharmacokinetics Assessment:analysis of data by PK blood samples.; | — |
Countries
China
Contacts
Public ContactAng Li
Beijing Di Tan Hospital, Capital Medical University
Outcome results
None listed