Invasive fungal infection
Conditions
Interventions
T-R group:Take the test formulation (T) 200mg (1 tablet) orally on an empty stomach. After 7 days, take the reference formulation (R) 200mg (1 tablet) orally on an empty stomach.
R-T group:After fasting, orally take the reference formulation (R) 200mg (1 tablet). After 7 days, after fasting, orally take the test formulation (T) 200mg (1 tablet).
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, methods of the trial, as well as possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form personally before any research procedures begin, ensuring participation throughout the entire trial; 2. Male or female aged 18 to 55 years (including 18 and 55 years); 3. Male weight >=50.0 kg, female weight >=45.0 kg; body mass index (BMI) within the range of 18.5–26.0 kg/m^2 (including boundary values, BMI = weight (kg) / height (m^2)); 4. Not planning pregnancy during the screening period and for the next 3 months, voluntarily using effective contraception (Appendix 2), and no plan for sperm or egg donation; 5. Able to communicate well with researchers and understand and comply with all requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Individuals allergic to voriconazole or its excipients (such as lactose), or known to be allergic to any medication, food, etc., or with a history of specific hypersensitivity (such as asthma, urticaria, atopic dermatitis), or having a severe allergic constitution, and deemed clinically significant by the researchers; 2. Individuals with difficulty swallowing or a history of any gastrointestinal disease that may affect drug absorption; 3. Individuals with any chronic or severe disease history affecting the circulatory, digestive, urinary, respiratory, nervous, immune, endocrine systems, mental disorders, or metabolic disorders, or any other disease that may interfere with the study results, or surgery within the past 3 months; 4. Individuals with any condition that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, and those with active pathological bleeding or a history of intracranial hemorrhage; 5. Individuals with poor vascular access or unable to tolerate intravenous puncture; 6. Individuals with a history of drug abuse within 6 months prior to screening, or who have used illegal drugs within 3 months prior to screening, including repeated or large-scale non-medical use of various narcotic and psychotropic drugs, or any positive result in urine screening tests for addictive substances such as morphine, methamphetamine (crystal meth), ketamine, MDMA (ecstasy), or tetrahydrocannabinol acid (cannabis); 7. Individuals who have participated in or are currently participating in another clinical trial within 3 months prior to screening; 8. Individuals who have donated blood (including component blood) or experienced significant blood loss (>=400 mL), received transfusions, or used blood products within 3 months prior to screening, or intend to donate blood (including blood components) during the trial or within 3 months after the trial; 9. Individuals who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicine, or vitamins within 14 days prior to screening; 10. Individuals who have taken any drugs that alter liver enzyme activity or interact with voriconazole within 1 month prior to administration; 11. Individuals who have received a vaccine within the past 3 months prior to screening, or plan to receive a vaccine during the trial; 12. Individuals who have smoked more than 5 cigarettes per day within the past 3 months prior to screening, or cannot stop using any tobacco products during the trial; 13. Individuals whose average daily alcohol intake exceeded 2 units in the 3 months prior to screening (1 unit = 360 mL beer, 150 mL red wine, or 45 mL distilled spirits), or who test positive for alcohol, or who do not agree to avoid alcohol during the trial; 14. Individuals who consumed excessive strong tea, coffee, and/or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL) within the 3 months prior to screening; 15. Individuals who have consumed strong tea, chocolate, coffee, caffeinated beverages, alcohol, foods or drinks containing xanthines (such as anchovies, sardines, beef liver, kidney, etc.), grapefruit (juice) or pomelo (juice), orange, dragon fruit, mango, lime, or starfruit within 48 hours prior to dosing; 16. Individuals with special dietary requirements who cannot accept a standardized diet; 17. Individuals with abnormal physical examination or vital signs deemed clinically significant by the investigato
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax;AUC0-8;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC_%Extrap;t1/2;Tmax;?z; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed