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Completed NCT05749380

Pharmacokinetics and Safety of AmBisome and DKF-5122

Conditions: Invasive Fungal Infections, Neutropenic Fever

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 38
Sponsor: Dongkook Pharmaceutical Co., Ltd.

Location: Korea, Republic of

Summary

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

Eligibility Criteria

Inclusion Criteria:Part 1. PatientsAge 19 years and olderEmpirical therapy for presumed fungal infection in febrile, neutropenic patientsVoluntarily decided to participate in the study and signed the informed consent formHaving contraception during the studyPart 2. Healthy subjectsAge 19 to 45 yearsBody weight 55 kg or more, within ±20% of the ideal body weightHaving no congenital or chronic disease within the last 5 years.Voluntarily decided to participate in the study and signed the informed consent formHaving contraception during the studyExclusion Criteria:Part 1. PatientsClinically significant conditions that may affect the pharmacokinetics of amphotericinHistory of diseases that may affect the pharmacokinetics of amphotericinHistory of drug abuseHistory of hypersensitivity to ingredients of investigational productsUnable to maintain proper contraceptionPregnant or breast-feedingThe following laboratory test results at screeningHemoglobin < 8.0 g/dLSerum Creatinine > 2x the UNLAST or ALT > 10x UNLSystolic blood pressure ≥ 140 mmHg or ≤ 90 mmHgDiastolic blood pressure ≥ 90 mmHg or ≤ 60 mmHgBefore the first administration of investigational productsParticipation to other clinical trials within 6 monthsWhole blood donation within 60 days or component within 30 days(Herbal) medicines that may affect the pharmacokinetics of amphotericin within 14 daysGrapefruit-containing foods within 7 daysExcessive exercise within 7 daysExcessive caffeine and alcohol consumption, or a smokerNot eligible due to other reasons at the investigator's discretionPart 2. Healthy subjectsClinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumorClinically significant conditions that may affect the pharmacokinetics of amphotericinHistory of diseases that may affect the pharmacokinetics of amphotericinHistory of drug abuseHistory of hypersensitivity to ingredients of investigational productsUnable to maintain proper contraceptionPregnant or breast-feedingThe following laboratory test results at screeningHemoglobin < 13.0 g/dLSerum Creatinine > 1.25 x UNLeGFR < 90 mL/min/1.73 m2AST or ALT > 1.25 x UNLTotal bilirubin > 1.25 x UNLCPK > 1.5 x UNLSystolic blood pressure ≥140 mmHg or ≤90 mmHgDiastolic blood pressure ≥ 90 mmHg or ≤60 mmHgArrhythmiaBefore the first administration of investigational productsParticipation to other clinical trials within 6 monthsWhole blood donation within 60 days or component within 30 daysDrugs that induce or inhibit drug metabolism enzymes within 30 daysVaccination within 7 daysPrescription drugs, herbal medicines, over-the-counters, or vitamins within 14 daysGrapefruit-containing foods within 7 daysExcessive exercise within 7 daysExcessive caffeine and alcohol consumption, or a smokerNot eligible due to other reasons at the investigator's discretion

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05749380). StuddyBuddy aggregates publicly available trial information.