Invasive Aspergillus
Conditions
Interventions
Group A:The test preparation was administered in the first cycle, and the reference preparation was administered in the second cycle
Group B:The reference preparation was administered in the first cycle, and the test preparation was administered in the second cycle
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Gender: Chinese healthy subjects, no gender limit, with appropriate gender ratio; 2. Age: over 18 years old (including 18 years old); 3. Male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and body mass index (BMI): 19.0-26.0kg/m^2 (Boundary values are included, body mass index (BMI) = weight (kg) / height ^2 (m^2)); 4. Subjects must give informed consent to this study before the trial, and voluntarily sign a written informed consent; 5. The subject can communicate well with the investigator and complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution or history of drug or food allergy, or known allergy to voriconazole; 2. The investigator considers clinically significant liver, kidney, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal (such as peptic ulcer disease), lung, tumor, immune, facial, skin, reproductive, blood or metabolism disorder or any other disease, or have a history of these diseases, or have had a history of major surgery, or factors that would jeopardize the safety of the subject or affect the results of the study; 3. During the trial and within 3 months after the end of the study, the subject or his partner has a pregnancy plan or is unwilling to use a medically acceptable contraceptive method, or the subject has a sperm/egg donation plan; 4. Subjects who are pregnant, breastfeeding, or subjects of childbearing age fail to take appropriate contraceptive measures within 14 days before enrollment, or those who used oral contraceptives within 30 days before the first dose of the study, or those who used long-acting estrogen or progestin injections or embedded tablets within 3 months before the trial; 5. Has a history of drug abuse, or positive drug abuse and drug tests, or habitually taking any drugs (including Chinese herbal medicine) or functional vitamins; 6. Use of any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicines within 14 days before screening; 7. Excessive smoking (>=5 cigarettes/day) within 3 months before screening, or smoking within 48 hours before the first dose of the study or a positive smoke test at screening, or smoking cannot be discontinued during the trial; 8. Previous alcoholism [that is, men drink more than 28 standard units per week and women drink more than 21 standard units per week (1 standard unit contains 14g of alcohol, such as 360ml of beer or 45ml of 40% alcohol or 150ml of wine) ], or frequent drinking (more than 14 standard units per week) within 3 months before screening, or alcohol breath test results greater than 0.0 mg/100 mL at screening, or ingest any alcoholic food or drink (such as liquor, beer, wine, rice wine, beer duck, fermented bean curd, egg yolk pie and Swiss roll containing edible alcohol) within 48 hours before the first dose of the study, or the test period cannot be interrupted; 9. Long-term drinking of excessive caffeinated beverages (more than 8 cups a day, 1 cup = 250mL), or ingest any food or drink containing caffeine (such as coffee, tea, cola, chocolate, etc.) within 48 hours before the first dose of the study, or the intake cannot be interrupted during the trial; 10. Within 48 hours before the first dose of the study, take any grapefruit fruit or products containing grapefruit, or the intake cannot be interrupted during the trial; 11. There are special requirements for diet and cannot comply with the unified diet; 12. Significantly abnormal diet (such as diet, low sodium) has been started within 4 weeks before screening; 13. Participated in other clinical trials within 3 months before screening; 14. Have been vaccinated within 1 month before screening; 15. Blood donation or massive blood loss (>=200mL) within 3 months before screening; 16. Difficulty in obtaining venous blood, or unable to tolerate venipuncture, or have a history of fainting and bleeding; 17. Any other factors that the investigator considers unsuitable for subjects to enter this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum blood concentration;the area under the plasma concentration-time curve from 0 to the last time point t;area under the plasma concentration-time curve from zero to infinity; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed