KCT0007923已完成未知
A pilot study to develop a population pharmacokinetic (PopPK) model for vancomycin in underweight subjects with normal renal function
Hanyang University Seoul Hospital0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
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 65(Year)（—）
- 性别
- All
入选标准
- •1) Subjects aged between 19 and 65 (inclusive) at screening
- •2) Subjects who have a body mass index greater than 14 4 kg/m2 (inclusive) and less than 18.5 kg/m2 (not inclusive)
- •3) If female, the subject should not be pregnant or breastfeeding, or the subject should have undergone sterilization operation.
- •4) Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol
- •5) Clinically confirmed as eligible to participate in this study based on physical examination, clnical laboratory tests, medical history
排除标准
- •1) Current or history of a clinically significant hepatic (severe hepatic impairment), renal (severe renal impairment), neurological, immune, respiratory, gastrointestinal, endocrine, hemato-oncological, cardiovascular (heart failure, Torsades de pointes, etc.), urological, psychiatric disease
- •2) Subjects with any of the following conditions
- •- history of shock due to vancomycin
- •- history of hypersensitivity due to vancomycin, peptide antibiotics, or aminoglycoside antibiotics
- •- history of hearing disorder due to peptide antibiotics or aminoglycoside antibiotics
- •- history of vestibular organ or cochlear damage
- •3) Subjects with any of the following results at the time of screening
- •- serum AST (SGOT), ALT (SGPT), T.bil, ALP: > ULN x 2.0
- •- eGFR using CKD-EPI equation: < 90 mL/min
- •4) Subjects with systolic blood pressure < 80 mmHg or > 150 mmHg, or diastolic blood pressure < 50 mmHg or > 100 mmHg at a sitting position with more than 3 min of resting
- •5) Subjects who plan to become pregnant or who refused to use birth control methods that are considered to be highly effective until 30 days after dosing (e.g., sterilization operation of the subject or the subject's partner, insertion of a contraceptive device, barrier methods (diaphragm or condom)
- •6) Participated in another bioequivalence study or clinical study and have been exposed to an investigational product within 6 months prior to the date of the first dose of this study
- •7) Donated whole blood within 2 months or blood components within 1 month, or received a blood transfusion within 1 month prior to the date of the first dose of this study
- •8) Subjects who can not quit drinking during admission
- •9) Subjects who can not quit smoking during admission
- •10) Positive results in serology tests (hepatitis B tests, human immunodeficiency virus [HIV] tests, hepatitis C tests, or syphilis tests [RPR])
- •11) Determined inappropriate for the study based on including but not limited to clinical laboratory tests, physical examination, electrocardiogram results
研究者
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