KCT0005944已完成未知
A clinical study to evaluate the pharmacokinetics of colistin and to explore biomarkers for nephrotoxicity in healthy volunteers
Kyung Hee University Hospital0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1) Subject who voluntarily agree with participation and sign informed consent approved by IRB, after a listened explanation about this clinical trial before the screening test
- •2) Healthy male between 19 and 45 years of age at the time screening tested
- •3) Bodyweight between 55 and 90 kg, and BMI between 18.0-27.0 kg/m^2 ? BMI = (weight [kg])/(height [m])^2
- •4) Subject who is determined to participate by a protocol by physical exam, clinical laboratory test, inquiry, and others, i.e., Subject who has no congenital or chronic disorders and symptoms or manifestations by internal medical examination
排除标准
- •1) History of hepatic, gastrointestinal, circulatory, renal, respiratory, endocrine, neurologic, immunologic, hematologic, psychiatric system, and neoplasm
- •2) History or clinical evidence of drug abuse
- •3) History or ongoing of significant allergy of prescription or over-the-counter medication
- •4) History of hypersensitivity against the investigational product, polymixin B or Colistin
- •5) Taking any prescription or traditional medication within 2 weeks or over-the-counter medication within 1 week before first investigational drug (IP) administration (but, in the investigator's judgment, when other conditions are suitable, the subject can participate in this trial.)
- •6) Participation in other clinical trials within 6 months before first IP administration (previous clinical trial's end date is the last administration day)
- •7) Before first IP administration, whole blood donation within 2 months, apheresis blood donation within 1 month, or blood transfusion within 1 month
- •8) Smoker over 10 cigarettes per day for 3 months before the first IP administration or who unable to quit smoking from 3 days ago before the first IP administration to last visit
- •9) Positive result on serology tests (for HBs antigen, HCV antibody, and HIV antibody)
- •10) Subject who meets any of the following criteria at screening test
- •? At the vital sign check, systolic blood pressure under 90 mmHg or over 150 mmHg, or diastolic blood pressure under 60 mmHg or over 100 mmHg
- •? At the electrocardiogram, QTc over 450 msec or manifestation or significant abnormal rhythm
- •? Renal insufficiency (as evidenced by an estimated eGFR(estimated Glomerular Filtration Rate) < 60 mL/min/1.73m^2 based on the MDRD(Modification of Diet in Renal Disease) formula)
- •? Hepatic insufficiency (liver enzymes in the blood (AST and ALT) over 1.5 times of upper limit of normal)
- •11) In the investigator's judgment, subject who has clinical abnormal manifestations of renal function (e.g., severe renal impairment)
- •12) Contraindications or precautions to investigational product (patients who have myasthenia gravis or porphyria)
- •13) Subject who refuse to practice acceptable methods of contraception as follows
- •A. Spouse/partner's use of an intrauterine device that proved in failure rate
- •B. Use of spermicide in conjunction with a barrier method(male or female)
- •C. Subject or partner's surgery (vasectomy, salpingectomy/tubal ligation, hysterectomy)
- •14) Subject who is unable to intake standard meal provided by the clinical trial center
- •15) Subject who is unable to read the trial contents such as the informed consent form or to understand this trial (e.g., who not able or limited ability to read to informed consent form)
- •16) Any other factor including laboratory test that, in the investigator's judgment, inappropriate to participate in this study
研究者
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