Fungal infections in adults and children aged 2 years and older
Conditions
Interventions
experimental group vs control group:Fasting intravenous infusion of test preparation or reference preparation
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following criteria to be selected: 1) Aged >= 18 years, both male and female; 2) The weight of male volunteers is >= 50.0 kg, and the weight of female volunteers is >= 45.0 kg, and the body mass index (BMI) is between 19 ~ 26 kg/m2, including the critical value; 3) Volunteers voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) Those who have previously or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry, and metabolic abnormalities, may interfere with the test results Any other diseases; 2) History of allergy to drugs, food or other substances; 3) Those who have received surgery within 4 weeks before the test, or plan to perform surgery during the study period; 4) Those who have taken any drugs (including Chinese herbal medicine) within 14 days before the test; 5) Any drug that inhibits or induces liver drug metabolism (such as inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) has been used within 30 days before the test; inhibitors-SSRIs Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 6) Participate in any clinical trial and take any clinical trial drugs within 3 months before the trial; 7) Those who donated blood or lost a lot of blood (>=200 mL, excluding blood loss during menstrual period in women), received blood transfusion or used blood products within 3 months before enrollment; 8) Pregnant or lactating women, and volunteers who cannot use one or more non-drug contraceptive measures during the trial period; 9) Those who have special requirements for diet and cannot follow a unified diet; 10) People who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 11) Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the test or those who cannot stop using any tobacco products during the test; 12) Alcoholics or those who drink regularly within 6 months before the test, that is, drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcoholic spirits or 150 mL of wine) or cannot during the test Stop using any alcohol-containing products; 13) Drug abusers or those who have used soft drugs (such as marijuana) 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 14) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or physical examination, electrocardiogram, laboratory examination abnormalities have clinical significance (Subject to the judgment of the clinical research doctor); 15) Creatinine clearance rate (CCr) < 90ml/min; 16) Color blindness, corrected vision < 0.8, abnormal visual field and abnormal intraocular pressure; 17) Subjects who are not suitable for intravenous drip administration; 18) Volunteers may not be able to complete the study due to other reasons or the researchers think they should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed