NCT05749380已完成1 期
Bioequivalence Study to Evaluate Pharmacokinetics and Safety of AmBisome and DKF-5122 in Indicated Patients and Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19 years and older
- •Empirical therapy for presumed fungal infection in febrile, neutropenic patients
- •Voluntarily decided to participate in the study and signed the informed consent form
- •Having contraception during the study
- •Healthy subjects
- •Age 19 to 45 years
- •Body weight 55 kg or more, within ±20% of the ideal body weight
- •Having no congenital or chronic disease within the last 5 years.
- •Voluntarily decided to participate in the study and signed the informed consent form
- •Having contraception during the study
排除标准
- •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
- •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
- •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
- •Excessive caffeine and alcohol consumption, or a smoker
- •Not eligible due to other reasons at the investigator's discretion
- •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
- •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
- •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
- •Excessive caffeine and alcohol consumption, or a smoker
- •Not eligible due to other reasons at the investigator's discretion
研究组 & 干预措施
1A(RT)
Other
Patients (AmBisome, DKF-5122)
干预措施: AmBisome (Drug)
1A(RT)
Other
Patients (AmBisome, DKF-5122)
干预措施: DKF-5122 (Drug)
1B(TR)
Other
Patients (DKF-5122, AmBisome)
干预措施: AmBisome (Drug)
1B(TR)
Other
Patients (DKF-5122, AmBisome)
干预措施: DKF-5122 (Drug)
2A(RT)
Other
Healthy subjects (AmBisome, DKF-5122)
干预措施: AmBisome (Drug)
2A(RT)
Other
Healthy subjects (AmBisome, DKF-5122)
干预措施: DKF-5122 (Drug)
2B(TR)
Other
Healthy subjects (DKF-5122, AmBisome)
干预措施: AmBisome (Drug)
2B(TR)
Other
Healthy subjects (DKF-5122, AmBisome)
干预措施: DKF-5122 (Drug)
结局指标
主要结局
Cmax
时间窗: 0 to 93 hr
Liposome encapsulated amphotericin B of healthy adult
AUClast
时间窗: 0 to 93 hr
Liposome encapsulated amphotericin B of healthy adult
次要结局
- tmax(0 to 93 hr)
- Cmax(0 to 93 hr)
- tmax,ss(0 to 93 hr)
- AUCinf(0 to 93 hr)
- CL/F(0 to 93 hr)
- PTF (peak to trough fluctuation ratio)(0 to 93 hr)
- CLss/F(0 to 93 hr)
- Vd,ss/F(0 to 93 hr)
- AUClast(0 to 93 hr)
- V/F(0 to 93 hr)
- t1/2(0 to 93 hr)
- Cmin,ss(0 to 93 hr)
- Cav,ss(0 to 93 hr)
研究者
研究点 (1)
Loading locations...
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