Fungemia caused by Aspergillus, candida infection, include respiratory tract fungemia, gastrointestinal fungemia.
Conditions
Interventions
A:Micafungin Sodium 50mg/60min
B:Micafungin Sodium 100mg/60min
C:Micafungin Sodium 150mg/min
Sponsors
China PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The voluntary to participate in clinical trials must be fully understand the test content and possible adverse reactions, and signed informed consent; 2. Health, aged 18 to 45 years of age. Sexually active women must agree; and commit to use a medically acceptable form of contraception during the screening period, throughout the study (including follow-up), and for at least 3 months after the last dose of test article; 3. Body mass index (BMI) in the range of 19.0 to 24.0 kg/m2 and body weight >=50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening: BMI = weight (kg)/[height (m)]2; 4. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray examination, and 12-lead electrocardiogram (ECG); 5. Have a high probability for compliance with and completion of the study.
Exclusion criteria
Exclusion criteria: 1. Presence or history of any disorder that may prevent the successful completion of the study; 2. Serious infection (infection associated with hospitalization and/or parenteral antimicrobial agents) within 1 month before test article administration or active infection at screening; 3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease; 4. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day; 5. History of alcohol or drug abuse that would interfere with the subject's ability to comply with protocol requirements; 6. Hepatic Insufficiency or kinetic Insufficiency. Physical and Laboratory Findings; 7.Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results; 8. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies; 9. Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine [PCP]); 10. History of any drug hypersensitivity; 11. Receipt of any investigational drug within 3 months beforethe screening period; 12. Consumption of any alcoholic beverages within 48 hours before study day 1; 13. Use of any over-the-counter drugs, including herbal supplements(except for the occasional use of acetaminophen [paracetamol] andvitamins <=100% of the recommended daily allowance) within 7 days before study day 1; 14. Women who were pregnancy, lactation; 15. Researchers who directly involved in the clinical trials and their families; 16. Donated blood within one month before the study, or intended to donate blood during the study period orr one month afte the study; 17. For any reason, the researchers believe that the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Micafungin Sodium plasma concentraion; | — |
Countries
China
Contacts
Public ContactBai Nan
Outcome results
None listed