Infected with the human immunodeficiency virus (HIV)
Conditions
Interventions
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18 years and above (inclusive), both male and female; 2. Male subjects must weigh >=50 kg, female subjects must weigh >=45 kg, and body mass index [BMI = weight (kg) / height (m^2)] must be within the range of 19–26 kg/m^2 (inclusive); 3. Subjects must be fully informed about the study and voluntarily sign a written informed consent form before participation; 4. Subjects must be able to communicate effectively with the investigator and complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Presence of major medical history or current conditions in the cardiovascular, digestive (including any history of gastrointestinal disorders affecting drug absorption), genitourinary, neurological/psychiatric, respiratory, hematological/lymphatic, endocrine, immune, musculoskeletal systems, infections, malignant tumors, etc., which are deemed clinically significant by the investigator; 2. History of specific allergies (e.g., asthma, urticaria, eczema), allergic constitution, or known allergy to any component of the investigational drug; 3. Difficulty swallowing, inability to adhere to a standardized diet, or lactose intolerance; 4. Major surgery within 6 months prior to the first dose (defined as surgery requiring general anesthesia), planned surgery during the study, or any history of surgery that may affect drug absorption, distribution, metabolism, or excretion (excluding appendectomy and hernia repair); 5. Use of any drugs known to inhibit or induce UGT1A1, UGT1A3, UGT1A9, CYP3A4, P-gp, or BCRP (e.g., efavirenz, etravirine, nevirapine, rifampicin, carbamazepine, tipranavir/ritonavir, fosamprenavir/ritonavir, St. John's wort, etc.), or any other drugs that may interact with the investigational drug (e.g., dofetilide, pilsicainide, amifampridine, etc.) within 30 days prior to the first dose; 6. Use of any prescription drugs, over-the-counter medications, herbal medicines, vitamins, or health supplements within 14 days prior to the first dose; 7. Abnormalities in physical examination, vital signs, chest X-ray, electrocardiogram, or laboratory tests (e.g., blood routine, blood biochemistry, urinalysis, four infectious disease markers, coagulation function, etc.) during screening that are considered clinically significant by the investigator; 8. Blood loss (excluding physiological blood loss in females) or blood donation (including component blood) =400 mL within 3 months prior to the first dose, or plans to donate blood or blood components during the study or within 3 months after study completion; 9. Participation in any clinical trial involving investigational drugs within 3 months prior to the first dose; 10. Vaccination within 30 days prior to the first dose or plans to receive vaccination during the study; 11. History of drug abuse within 12 months prior to the first dose, and/or use of illicit drugs within 3 months prior to the first dose, and/or habitual use of any medications (including herbal medicines), or positive urine drug screen; 12. Average daily smoking of more than 5 cigarettes within 3 months prior to the first dose, or unwillingness to abstain from tobacco products during the study; 13. Regular alcohol consumption within 6 months prior to the first dose (defined as >14 units of alcohol per week 1 unit = 360 mL beer [5% alcohol], 45 mL spirits [40% alcohol], or 150 mL wine [12% alcohol]), or inability to abstain from alcohol from the time of informed consent until study completion, or positive alcohol breath test; 14. Excessive daily consumption of tea, coffee, and/or caffeinated beverages (>8 cups per day, 1 cup = 250 mL) within 3 months prior to the first dose, or unwillingness to abstain from tea, coffee, caffeinated foods, grapefruit (or grapefruit juice), and/or poppy-containing products 48 hours before admission and during the hospitalization period; 15. Plans for reproduction (including sperm or egg donation) from the time of informed consent until 3 months after the last dose, and/or unwillingness to use e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Tmax; | — |
Countries
China
Contacts
Public ContactHan Yangyun, Fan Lianlian
Deyang People's Hospital
Outcome results
None listed