Loading clinical trials...

Pharmacokinetics and Safety of AmBisome and DKF-5122 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics and Safety of AmBisome and DKF-5122

Bioequivalence Study to Evaluate Pharmacokinetics and Safety of AmBisome and DKF-5122 in Indicated Patients and Healthy Adults

NCT05749380•Dongkook Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Part 1. Patients
•1. Age 19 years and older
•2. Empirical therapy for presumed fungal infection in febrile, neutropenic patients
•3. Voluntarily decided to participate in the study and signed the informed consent form
•4. Having contraception during the study
•Part 2. Healthy subjects
•1. Age 19 to 45 years
•2. Body weight 55 kg or more, within ±20% of the ideal body weight
•3. Having no congenital or chronic disease within the last 5 years.
•4. Voluntarily decided to participate in the study and signed the informed consent form
+1 more criteria

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
+37 more criteria

Locations (1)

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, Seocho-gu, South Korea

Key Dates

Start Date

September 7, 2020

Primary Completion Date

January 28, 2022

Completion Date

January 28, 2022

Last Updated

March 1, 2023

Enrollment

ACTUAL participants

Conditions

Invasive Fungal InfectionsNeutropenic Fever

Interventions

AmBisome

DRUG

DKF-5122

DRUG

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

NCT06105411

Invasive Fungal Infections

View study

RECRUITINGPHASE4

Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

NCT07016165

Neutropenic FeverAcute Lymphoblastic Leukemia+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pharmacokinetics and Safety of AmBisome and DKF-5122

Inclusion Criteria

Exclusion Criteria

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

Breath Analysis for the Detection of Invasive Fungal Infections

Usefulness of PET-CT for Invasive Fungal Infection

L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

Hyperbaric Oxygen Therapy Used on Severely Injured Healthy Individuals With Fungal Infections