None
Conditions
Interventions
TR group:In the first period, one tablet of the test formulation is taken orally under fasting conditions, and in the second period, one tablet of the reference formulation is taken orally under fasti
RT group:In the first period, one tablet of the reference formulation is taken orally under fasting conditions, and in the second period, one tablet of the test formulation is taken orally under fasti
Sponsors
Tongji Hosptial Affiliated to Tongji Medical College of Huazhong University fo Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy participants must meet all of the following criteria to be eligible for inclusion: 1. Age >= 18 years and = 50.0 kg, and female subjects must weigh >= 45.0 kg. 3. Health status: Proven to be healthy through medical history inquiry, physical examination, and laboratory tests. 4. Participants must provide informed consent to participate in the study and voluntarily sign the informed consent form before the trial. 5. Participants must be able to communicate well with the investigators and follow the study protocol to complete the research.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following conditions will not be eligible for this trial: 1. Abnormalities in physical examination, vital signs, laboratory tests (such as complete blood count, blood biochemistry, urinalysis, coagulation function, HBsAg, HCV antibodies, HIV antibodies, syphilis antibodies), ophthalmological examination, or 12-lead ECG, as judged by the study physician to be clinically significant; AST and ALT > 1×ULN, serum creatinine > 1×upper limit of normal (ULN). 2. Clinical manifestations or history of diseases that need to be excluded, including but not limited to neurological (e.g., epilepsy), cardiovascular (e.g., myocardial infarction, heart failure, hypertension), renal, hepatic, gastrointestinal (e.g., gastrointestinal bleeding, ulcers), respiratory (e.g., COPD, asthma), metabolic (e.g., diabetes), and musculoskeletal disorders, as judged by the study physician to be unsuitable for inclusion. 3. Having undergone surgery that affects drug absorption, distribution, metabolism, or excretion, as judged by the study physician to be unsuitable for inclusion. 4. Prone to allergic reactions (e.g., rashes, eczema, urticaria, asthma) or known allergies to voriconazole or other components of the product. 5. History of orthostatic hypotension or frequent syncope. 6. Lactose intolerance or rare hereditary galactose intolerance, primary lactase deficiency, or glucose-galactose malabsorption. 7. History of psychiatric disorders. 8. History of drug abuse, drug dependence, or drug use within 5 years prior to screening. 9. Smoking more than 5 cigarettes per day within 3 months prior to screening; or positive urine cotinine test during the screening period. 10. Inability to tolerate venous blood sampling. 11. History of alcohol abuse within 3 months prior to screening (more than 14 units of alcohol per week, 1 unit = 360 ml of beer or 45 ml of 40% alcohol spirits or 150 ml of wine), or positive alcohol breath test during the screening period. 12. Blood donation or significant blood loss (>400 ml) within 3 months prior to screening. 13.Use of any prescription or over-the-counter medication within 14 days prior to the first administration of the study drug (excluding topical or local preparations). 14. Use of any medication that can alter the activity of liver enzyme CYP3A4 within 1 month prior to the first administration of the study drug (e.g., CYP3A4 inducers - dexamethasone, carbamazepine, phenytoin, phenobarbital, etc.; CYP3A4 inhibitors - itraconazole, erythromycin, clarithromycin, etc.). 15. Consumption of excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup = 250 ml) within 3 months prior to screening. 16. Consumption of any alcohol-containing products within 24 hours prior to the administration of the study medication. 17. Consumption of grapefruit or its products within 7 days prior to the administration of the study medication. 18. Participation in any drug clinical trial and use of any trial medication within 3 months prior to screening. 19. New onset of disease during the pre-study screening phase or before the administration of the study medication. 20. Special dietary requirements that cannot comply with a standardized diet. 21. Female participants who are breastfeeding or have a positive pregnancy test during the screening period. 22. Participant (including their partners) who plan to conceive within 2 weeks before administration to 1 month after the last administration of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;Area under the curve in the time from administration to the lowest detectable blood concentration;Area under the curve from administration to extrapolation to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak concentration;Plasma elimination half-life; | — |
Countries
China
Contacts
Public ContactLiu Dong, Ren Xiuhua
Tongji Hosptial Affiliated to Tongji Medical College of Huazhong University fo Science and Technology
Outcome results
None listed