A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects

Inclusion criteria

• Subjects fully understand and voluntarily participate in this study and sign informed consent.
• Healthy female and male volunteers aged 18-55 years.
• Body weight ≥ 50 kg for male and ≥ 45 kg for female with a body mass index (BMI) in the range of 19.0 to 26.0 kg/m2 (inclusive).
• Subjects must be in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
• Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

• History of allergic reactions to amphotericin B or its analogs. History of allergy to two or more kinds of drugs or food.
• Subjects have any history of surgery, trauma that may affect the safety of the study or the intracorporal process of the drug, or have a surgical schedule during the study period.
• Use of any prescription or over the counter medication within 14 days prior to screening.
• History of drug abuse within 6 months prior to screening.
• Smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to stop using any tobacco products during the trial period.
• Consumption of alcohol in excess of 14 units/week within 3 months prior to screening.
• Consumption excessive amounts of tea, coffee and/or caffeine-rich beverages daily within 3 months prior to screening.
• Participation in other trial within 3 months prior to screening.
• Donation or loss of more than 400 mL blood within 3 months prior to screening.
• Subject (female) is lactating or pregnant.
• Subject who cannot tolerate venipuncture or have a history of needle and blood sickness.
• Subject who has special requirements on diet and cannot accept the uniform diet.
• Subject who has childbearing plan, unwillingness or inability to use effective contraceptives from 2 weeks before the screening to 6 months after the last dosing of the study drug.
• Any positive test result for Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-syphilis spirochete.
• Female subjects with positive pregnancy test results during the screening period or during the study.
• Positive test result for alcohol screening or drug abuse.
• AST or ALT, total or direct bilirubin, alkaline phosphatase and creatinine are above the upper limit of normal and potassium is below the lower limit of normal; any other abnormalities in laboratory tests and ancillary tests that are judged by the investigator to be clinically significant.
• Not suitable for this study as determined by the investigator due to other reasons.