An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different
 liposomal amphotericin B injections after single IV infusion at the same dose in normal
 healthy subjects.
Inclusion Criteria:

 1. Subjects must be adults (> 20 years old) in good health on the basis of medical
 history, physical examination, electrocardiogram, chest X-ray, and routine laboratory
 evaluations.

 2. Vital signs (after 3 minutes resting in a upright position) which are within the
 following ranges: Ear body temperature between 35.0-37.5 °C. Systolic blood pressure,
 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm

 3. Fasting blood glucose < 100 mg/dL.

 4. Body weight must be above 50 kg for men and 45 kg for women and within 20% of ideal
 body weight.

 5. Negative urine drug screen at clinic check-in before each dosing

 6. Able to sign informed consent prior to study.

 7. Able to communicate well with the investigator and comply with the requirements of the
 study.

 8. Pregnancy tests (female only): negative reaction

 Exclusion Criteria:

 1. Use of any prescription or over the counter medication within 14 days prior to
 investigational products administration; with the exception of acetaminophen (not more
 than 2 g/day) or vitamins.

 2. A plan to take concomitant medications while enrolled in the study, with the exception
 of acetaminophen (not more than 2 g/day) or vitamins.

 3. Presence of any acute or chronic medical condition within 2 weeks prior to
 investigational products administration, including but not limited to: hepatic,
 gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic,
 respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease
 including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute
 infection; or other conditions that would interfere with the absorption, distribution,
 metabolism, or excretion of drugs. Evidence of impaired renal function as indicated by
 clinically significant abnormal creatinine or BUN values or abnormal urinary
 constituents (e.g., albuminuria) as judged by the investigator. Evidence of liver
 disease, hepatitis B, hepatitis C or liver injury as indicated by an clinically
 significant abnormal liver function profile such as GOT, GPT, g-GT, alkaline
 phosphatase, serum bilirubin, HBs Ag, or HCV Ab as judged by the investigator.

 4. Hemoglobin less than 12 g/dL

 5. Participation in any clinical investigation within 2 months or 5 half-lives, whichever
 is longer, prior to investigational products administration.

 6. Donation or loss of more than 500 mL blood within 3 months prior to investigational
 products administration.

 7. Subject is known for HIV infected.

 8. Known allergy or hypersensitivity to amphotericin B or its analogs.

 9. History of drug or alcohol abuse within 12 months prior to investigational products
 administration ; current consumption of alcohol in excess of 28 units/week (one unit
 is 6 oz of beer, ½ oz of hard liquor, or 2 oz of wine)

 10. Subjects who, in the opinion of the investigator, should not participate in the study
 or may not be capable of following the study schedule for any reason.

 11. Consumption of more than 36 to 40 oz (1.1-1.2 L) of caffeine-containing beverages per
 day

 12. Consumption of any products containing grapefruit in the 3 days before clinic
 check-in.