Mycotic infection
Conditions
Interventions
Fasting Group 1:T-R
Fasting Group 2:R-T
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects over 18 years old (including 18 years old), both male and female; 2) The body weight of male >= 50.0kg, female >= 45.0kg, body mass index (BMI) between 19.0 and 26.0kg/m2 (including boundary value); 3) Previous medical history, vital signs, physical examination, blood routine examination, urine routine examination, blood biochemical examination, ECG, chest CT examination were normal or abnormal without clinical significance; 4) The subjects and their partners were able to take effective contraceptive measures during the trial and had no family planning during the trial and within 6 months after the end of the trial; 5) The subjects fully understood the content, process and possible adverse reactions of the test and signed the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Those with surgery or other medical or drug trials within 3 months before screening; 2) Blood donation or loss of 400 ml or more within 3 months before screening; 3) Having any serious clinical disease history such as respiratory circulatory system, digestive system, urinary system, blood system, endocrine system, nervous system or mental disorder or any other disease or physiological condition that can interfere with the test results; 4) Have a history of dysphagia or any gastrointestinal disease affecting drug absorption (such as gastrectomy, atrophic gastritis, gastrointestinal bleeding, obstruction, etc.); 5) Rare, congenital galactose intolerance, Lapp lactase deficiency or glucose galactose absorption disorder; 6) Hepatitis B surface antigen, Treponema pallidum antibody, human immunodeficiency virus antibody or hepatitis C virus antibody positive; 7) Those who are allergic to voriconazole (including other triazole antifungal drugs) or any component of the auxiliary materials of the study drug or allergic constitution (such as allergic to two or more drugs, food and pollen); 8) Those who have the habit of smoking (more than 5 cigarettes per day on average) within 3 months before screening or can not stop using any tobacco products during the trial period; 9) Those who drank alcohol (more than 14 units of alcohol per week: 1 unit = 285ml of beer, or 25ml of spirits, or 100ml of wine) within 3 months before screening or drank any alcohol product or alcohol breath test positive within 24 hours before administration; 10) There was a history of drug abuse or positive drug abuse screening within 6 months before screening; 11) Those who took any prescription drugs within 2 weeks before screening; 12) Any over-the-counter medicine, vitamin product or Chinese herbal medicine taken within 1 week before screening; 13) It is difficult to take blood from vein, and can't bear to take blood from vein puncture or have history of syncope and needle; 14) Within 48 hours before administration, eat fruits that affect drug metabolism, such as pitaya, mango, grapefruit, or foods rich in xanthine, and / or drink caffeinated beverages, such as chocolate, tea, coffee, cola, etc.; 15) Those who fail to follow the unified diet (such as having special requirements for diet, not tolerant of standard food, etc.); 16) Pregnant and lactating women; 17) Novel coronavirus pneumonia affected areas novel coronavirus pneumonia, residents' history of tourism and history of new crown pneumonia diagnosed or suspected patients were closely contacted during the first 14 days. 18) The investigator judged that the subjects were not suitable to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t, AUC0-8, Cmax, t1/2z, ?z, Tmax and AUC_%Extrap;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| physical examination (blood pressure, pulse, temperature,etc.);ECG;laboratory examination (blood routine examination, routine urine examination, blood biochemical etc.); | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed