Patients with fungal infections
Conditions
Interventions
Group A:On an empty stomach, the test formulation was administered in the first cycle and the reference formulation was administered in the second cycle. The cleaning period between cycles is 7 days
Group B:On an empty stomach, the reference formulation was administered in the first cycle and the test formulation was administered in the second cycle. The cleaning period between cycles is 7 days
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) The subjects must have informed consent to the experiment, fully understand the content, process, and potential adverse reactions before the experiment, and voluntarily sign a written informed consent form; 2) The subjects are able to communicate well with the researchers and complete the experiment according to the protocol requirements; 3) Gender: male and female; 4) Age: 18-60 years old (including boundary value); 5) Weight: Male weight = 50kg, female weight = 45kg, and body mass index [BMI=weight (kg)/height 2 (m2)] within the range of 19.0-26.0kg/m2 (including boundary values); 6) The subject and their partner have no family planning (including sperm and egg donation plans) and voluntarily take effective contraceptive measures (non medication during the trial period) within 3 months after signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals who are allergic to triazole antifungal drugs such as voriconazole, fluconazole, itraconazole, posaconazole, or ketoconazole, or any component of this product (such as sulfobutylbetacyclodextrin sodium), or have a history of allergies to two or more drugs or foods; 2) Screening for clinically significant diseases, including but not limited to respiratory system, circulatory system, cardiovascular system, digestive system, blood system, endocrine system, immune system, skin system, psychiatric system, facial features, and other related diseases; 3) The results of various vital signs, physical examinations, electrocardiogram examinations, fundus examinations, chest CT scans, and laboratory examinations have been determined by the research doctor to be clinically significant; 4) Previous history of cardiovascular system diseases, electrolyte disorders (such as hypomagnesemia, hypokalemia, hypocalcemia, etc.), hypoglycemia, hypotension, neurological disorders, psychiatric disorders, liver and kidney dysfunction, blurred vision, optic neuritis, papilledema, pancreatitis, photosensitive dermatitis, or family genetic history; 5) Individuals with any disease that increases the risk of bleeding, such as acute gastritis or active ulcer with bleeding, clinically significant thrombocytopenia or anemia, as well as those with active pathological bleeding or a history of intracranial hemorrhage; 6) Have a history of hepatitis B, hepatitis C, AIDS, and syphilis, or have one or more abnormalities clinically significant in hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, and treponema pallidum antibody tests; 7) Those who have undergone major surgical procedures within the first 3 months of screening, or those who plan to undergo surgical procedures during the study period; 8) Those who have lost more than 200mL of blood (excluding female physiological period) within the first 3 months of screening, or those who have used blood products or transfusions, or those who plan to donate blood during the study period and within 3 months after the last administration; 9) Previous history of drug abuse, or screening for individuals who have used drugs within the first 3 months; 10) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and vitamins that affect drug absorption, distribution, metabolism, and excretion within the first 2 weeks of screening; 11) Those who have used any drugs that inhibit or induce liver drug metabolism enzymes within the first month of screening (such as inducers - barbiturates, carbamazepine, phenytoin sodium, phenobarbital, glucocorticoids; inhibitors - omeprazole, itraconazole, cimetidine, ritonavir, macrolides, nitroimidazoles, verapamil, fluoroquinolones, rifampicin, St. John's wort, ketoconazole, etc.); 12) Those who have used any drugs that interact with voriconazole within the first month of screening (such as CYP3A4 substrate - astemizole, cisapride; CYP450 inducer; P-gp inducer; CYP2C9 substrate; anticoagulants; immunosuppressants; non-steroidal anti-inflammatory drugs; ranitidine, etc.); 13) Those who smoke an average of more than 5 cigarettes per day within the first 3 months of screening, or those who do not agree to avoid using any tobacco products during their stay; 14) Regular drinkers within the first 6 months of screening, i.e. those who consume more than 14 units of alcohol per week (1 unit=360mL of 5% alcohol beer, 45mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;T1/2;AUC_%Extrap;Safety evaluation indicators; | — |
Countries
China
Contacts
Public ContactMai Gang, Fan Lianlian
Deyang People's Hospital
Outcome results
None listed