Non-nucleoside reverse transcriptase inhibitors, and other antiretroviral drugs in combination with HIV / AIDS.
Conditions
Interventions
75mg:ACC007 tablets 75mg once a day
150mg:ACC007 tablets 150mg once a day
300mg:ACC007 tablets 300mg once a day
150mg:Group A is administrated with single dose after fasting on Day 1 , and single dose after eating on Day 15.
150mg:Group B is administrated with single dose after eating on Day 1 , and single dose after fasting on Day 15.
Sponsors
Beijing You An Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Subject 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 and 45 years of age; 3) A subject with body weight = 45 kg and body mass index (BMI) between 19 to 25 kg/m2 BMI= weight (kg) / {height (m)}2; 4) No birth plan within six months. For females of child-bearing potential only: – Test negative for pregnancy at the time of screening; – 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 abstinence) 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) Under a comprehensive physical examination (including general physical examination, hematuria routine, blood biochemical tests, coagulation, chest X-ray, B ultrasound and ECG, etc.), liver and kidney function and the rest of the indicators are in the normal range.
Exclusion criteria
Exclusion criteria: 1) A subject with a history of allergies to drugs (aspirin, antibiotics, etc.), or history of clinically significant allergies; 2) A subject with clinical evidence or history of hepatic, renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease(eg, fatty liver or hyperlipidemia); 3) A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug; 4) A female subject who is pregnant or nursing; 5) Patients who are taking any of the following medications; Bepridil, cisapride, midazolam, pimozide, triazolam, Ergot medications (e.g. Wigraine, cagergot, St. Johns wort), Phenobarbitol; 6) The value of AST or ALT is greater than 1.25 times the upper limit of the reference range; 7) A positive Hepatitis B surface antigen or positive Hepatitis C antibody at screening; 8) A positive test for HIV antibody; 9) A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration; 10) A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration; 11) A subject who has donated or had loss of = 400 mL of blood within 8 weeks prior to start of administration of study drug; 12) A subject smokes =5 cigarettes per day; Drink more than 14 units of alcohol per week (1 unit = 285 ml of beer; or 25 ml of spirits; or 1 cup of wine); 13) A subject with a history of drug abuse, or a positive urine drug screening test; 14) A subject who heavily takes caffeine or caffeine-containing products, or takes grapefruit, grapefruit juice, or grapefruit-containing products; 15) A subject who is unable to eat a standardized meal offered by the study center; 16) Systolic blood pressure outside the range of 80 to 140 mm Hg, or diastolic blood pressure outside the range of 60 to 85 mm 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) A subject who cannot swallow up to 8 uncoated tablets (8 mm diameter); 18) The investigator judges the subject 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 ContactMeixia Wang
Beijing You An Hospital, Capital Medical University
Outcome results
None listed