Pharmacokinetics and Safety of AmBisome and DKF-5122

Exclusion Criteria

• •Part 1. Patients
• •1. Clinically significant conditions that may affect the pharmacokinetics of amphotericin
• •2. History of diseases that may affect the pharmacokinetics of amphotericin
• •3. History of drug abuse
• •4. History of hypersensitivity to ingredients of investigational products
• •5. Unable to maintain proper contraception
• •6. Pregnant or breast-feeding
• •7. The following laboratory test results at screening
• •* Hemoglobin \< 8.0 g/dL
• •* Serum Creatinine \> 2x the UNL
• •* AST or ALT \> 10x UNL
• •* Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg
• •* Diastolic blood pressure ≥ 90 mmHg or ≤ 60 mmHg
• •8. Before the first administration of investigational products
• •* Participation to other clinical trials within 6 months
• •* Whole blood donation within 60 days or component within 30 days
• •* (Herbal) medicines that may affect the pharmacokinetics of amphotericin within 14 days
• •* Grapefruit-containing foods within 7 days
• •* Excessive exercise within 7 days
• •9. Excessive caffeine and alcohol consumption, or a smoker
• •Part 2. Healthy subjects
• •1. Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor
• •2. Clinically significant conditions that may affect the pharmacokinetics of amphotericin
• •3. History of diseases that may affect the pharmacokinetics of amphotericin
• •4. History of drug abuse
• •5. History of hypersensitivity to ingredients of investigational products
• •6. Unable to maintain proper contraception
• •7. Pregnant or breast-feeding
• •8. The following laboratory test results at screening
• •* Hemoglobin \< 13.0 g/dL
• •* Serum Creatinine \> 1.25 x UNL
• •* eGFR \< 90 mL/min/1.73 m2
• •* AST or ALT \> 1.25 x UNL
• •* Total bilirubin \> 1.25 x UNL
• •* CPK \> 1.5 x UNL
• •* Systolic blood pressure ≥140 mmHg or ≤90 mmHg
• •* Diastolic blood pressure ≥ 90 mmHg or ≤60 mmHg
• •* Arrhythmia
• •9. Before the first administration of investigational products
• •* Participation to other clinical trials within 6 months
• •* Whole blood donation within 60 days or component within 30 days
• •* Drugs that induce or inhibit drug metabolism enzymes within 30 days
• •* Vaccination within 7 days
• •* Prescription drugs, herbal medicines, over-the-counters, or vitamins within 14 days
• •* Grapefruit-containing foods within 7 days
• •* Excessive exercise within 7 days
• •10. Excessive caffeine and alcohol consumption, or a smoker