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The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1A(RT) | Other | Patients (AmBisome, DKF-5122) |
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| 1B(TR) | Other | Patients (DKF-5122, AmBisome) |
|
| 2A(RT) | Other | Healthy subjects (AmBisome, DKF-5122) |
|
| 2B(TR) | Other | Healthy subjects (DKF-5122, AmBisome) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AmBisome | Drug | Reference, dose of 3 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Liposome encapsulated amphotericin B of healthy adult | 0 to 93 hr |
| AUClast | Liposome encapsulated amphotericin B of healthy adult | 0 to 93 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Unbound Amphotericin B of healthy adult | 0 to 93 hr |
| AUClast | Unbound Amphotericin B of healthy adult | 0 to 93 hr |
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Inclusion Criteria:
Part 1. Patients
Part 2. Healthy subjects
Exclusion Criteria:
Part 1. Patients
Clinically significant conditions that may affect the pharmacokinetics of amphotericin
History of diseases that may affect the pharmacokinetics of amphotericin
History of drug abuse
History of hypersensitivity to ingredients of investigational products
Unable to maintain proper contraception
Pregnant or breast-feeding
The following laboratory test results at screening
Before the first administration of investigational products
Excessive caffeine and alcohol consumption, or a smoker
Not eligible due to other reasons at the investigator's discretion
Part 2. Healthy subjects
Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor
Clinically significant conditions that may affect the pharmacokinetics of amphotericin
History of diseases that may affect the pharmacokinetics of amphotericin
History of drug abuse
History of hypersensitivity to ingredients of investigational products
Unable to maintain proper contraception
Pregnant or breast-feeding
The following laboratory test results at screening
Before the first administration of investigational products
Excessive caffeine and alcohol consumption, or a smoker
Not eligible due to other reasons at the investigator's discretion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | Seocho-gu | 06591 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41513548 | Derived | Han S, Yim DS, Han S, Choi S, Cho SY, Lee R, Nho D, Baek HJ, Lee DG. Pharmacokinetic Equivalence of AmphosomTM, a Newly Developed Liposomal Amphotericin B, to AmbisomeⓇ. Clin Ther. 2026 Feb;48(2):186-195. doi: 10.1016/j.clinthera.2025.12.009. Epub 2026 Jan 8. |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009503 | Neutropenia |
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| ID | Term |
|---|---|
| C068538 | liposomal amphotericin B |
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| DKF-5122 | Drug | Test, dose of 3 mg/kg |
|
| AUCinf | Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult | 0 to 93 hr |
| tmax | Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult | 0 to 93 hr |
| t1/2 | Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult | 0 to 93 hr |
| CL/F | Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult | 0 to 93 hr |
| V/F | Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult | 0 to 93 hr |
| Cmin,ss | Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient | 0 to 93 hr |
| Cav,ss | Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient | 0 to 93 hr |
| tmax,ss | Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient | 0 to 93 hr |
| t1/2 | Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient | 0 to 93 hr |
| PTF (peak to trough fluctuation ratio) | Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient | 0 to 93 hr |
| CLss/F | Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient | 0 to 93 hr |
| Vd,ss/F | Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient | 0 to 93 hr |
| D000380 |
| Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |