None listed
Conditions
Interventions
4?6?8 mg/kg and multiple dose group:None
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Subjects who can understand and are willing to strictly abide by the clinical trial protocol to complete the trial and sign the informed consent form; (2) Male and female subjects aged 18 to 45 (including 18 and 45) have the same proportion of men and women; (3) Weight >= 50.0kg; Body mass index (BMI) is within the range of 19.0~24.0 kg/m2 (including the critical value), and the weight (kg) of the same batch of subjects should not be too different; (4) The subjects (including their partners) promised that they had no fertility plan, no sperm donation plan and no egg donation plan from 2 weeks before screening to 3 months after the last administration, and that they would voluntarily take appropriate contraceptive measures.
Exclusion criteria
Exclusion criteria: (1) Have a history of allergy to voriconazole, fluconazole, itraconazole, posaconazole or ketoconazole, or have a history of drug allergy or allergy to two or more kinds of food and contact substances; (2) Past or present patients with respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and other serious diseases and chronic disease history, or other diseases and physiological conditions that may affect the research results as judged by the research doctor; (3) The results of physical examination, vital sign monitoring, ECG examination and laboratory examination, which are judged by the researcher to be clinically significant; (4) 12 lead ECG showed male QTc >= 440ms or female QTc >= 450ms or other arrhythmia with clinical significance judged by the research doctor; (5) Liver function test indicators (total bilirubin, direct bilirubin, AST, ALT) exceed the upper limit of normal values; (6) Color blindness, color weakness, visual field damage or vision less than 0.8, or the researcher thinks that the abnormality is clinically significant; (7) Any abnormality of hepatitis B virus surface antigen, Treponema pallidum antibody, human immunodeficiency virus antibody and hepatitis C virus antibody with clinical significance; (8) Those who have massive hemorrhage or active hemorrhage or thrombocytopenia in the past, or have a past and family history of coagulopathy, or have other bleeding tendencies; (9) Those who have undergone major surgery within 3 months before screening, or who plan to undergo surgery during the trial, or who have previously undergone surgery that may significantly affect the distribution, metabolism and excretion of the study drug in the body; (10) Those who have participated in clinical trials of any drug or medical device within 3 months before screening; (11) The total blood loss reached or exceeded 400ml due to blood donation or other reasons within 3 months before screening (except female physiological blood loss); (12) Those who cannot tolerate venous puncture, have a history of needle and blood fainting, or have potential difficulty in venous blood collection; Those who have used any drugs (including prescription drugs, over-the-counter drugs, vitamin products, Chinese herbal medicine, drugs that change the activity of liver drug enzymes or long-term injections, implants) or health products within 30 days before screening; (13) Those who have a history of drug abuse or drug abuse, or who are positive in urine drug screening (morphine, methamphetamine, ketamine, cocaine, tetrahydrocannabinoid acid, dimethylenedioxymethamphetamine); (14) Those who drank more than 14 units of alcohol per week within 3 months before screening (1 unit of alcohol ˜ 360 ml of beer or 45 ml of spirits with 40% alcohol content or 150 ml of wine), or those who could not abstain from drinking during the test, or those whose alcohol breath test results were greater than 0.0 mg/100 ml; (15) Those who smoke >= 5 cigarettes per day within 3 months of the screening period or cannot stop using any tobacco products during the test period; (16) Those who drink excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup=250 ml) every day within 3 months before screening; (17) Have eaten or disagreed with fasting foods or beverages rich in caffeine or xanthine (such as chocolate, coffee, strong tea, etc.) within the first 7 days of randomi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic enzyme genotyping; | — |
Countries
China
Contacts
Public ContactXin Tian
Outcome results
None listed