fungal infection
Conditions
Interventions
investigational products group:investigational products
control group:reference listed drug
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy volunteers must be give written informed consent and fully understand the study. 2.Ability to comply with all study requirements. 3.healthy volunteers must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until 6 months of last dose administration. 4.Male and female healthy volunteers aged between 18 to 55 years (both inclusive). 5.Body mass index (BMI) ranges from 18.0 to 28.0 kg/m2, body weight >= 50 kg for male and 45 kg for female. 6.Medically healthy subjects with clinically normal laboratory profiles and ECGs. 7.No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities; No preparation allergies, serious infection or injury, etc.
Exclusion criteria
Exclusion criteria: 1.Smoking >= 5 cigarettes per day during the period from 3 months to 1 month before the study,or using any type of tobacco products within 1 month before the trial; 2.Known allergy or hypersensitivity reactions to any components of conventional or liposomal Amphotericin B formulations. Known allergy or hypersensitivity reactions to two or more drugs and foods; 3.AST, ALT, total bilirubin, direct bilirubin ,alkaline phosphatase, Serum creatinine concentration greater than the upper limit of normal (ULN). Clinically significant screening laboratory parameters and accessory examination in the opinion of the investigator; 4.Average weekly drinking of more than 14 units of alcohol in the 180 days before the trial, 1 unit =360 mL beer or 45 mL 40% spirits or 150 mL wine; 5.Subjects who have donated blood or lost blood equal to or more than 400 mL within 90 days before the test, or intend to donate blood or blood components during or within 3 months after the test; 6.Subjects enroll in other clinical trials and take corresponding experimental drugs within 90 days before the trial, or participate in other clinical trials; 7.Pregnant or lactating women; 8.A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test; 9.Subjects with acute disease prior to the study; 10.Subjects had taken Chocolate, any food or beverage contain caffeine or xanthine within 24 hours before the test; 11.Subjects had taken any alcoholic product within 24 hours before the test; 12.Positive results for alcohol or drugs.History of drug abuse in the past 5 years or had used drugs in the 3 months prior to the test; 13.Subjects who have the difficulty in venous blood, or can not tolerate venipuncture, or have a history of dizziness; 14.Other situations that the researchers considered unsuitable to enroll the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t; | — |
Countries
China
Contacts
Public ContactVincent Li
Beijing Tide Pharmaceutical Co., Ltd.
Outcome results
None listed