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A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen

2018年11月29日 更新者:SeungHwan Lee、Seoul National University Hospital

A Pilot Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen Based on the Population Pharmacokinetic Model and the Influence of Sex on the Pharmacokinetics of Voriconazole

A pilot study was performed to evaluate the appropriateness of the voriconazole dosing regimen based on the population pharmacokinetic model and the influence of sex on the pharmacokinetics of voriconazole

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

11

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Seoul、大韩民国、03080
        • Seoul National University Hospital Clinical Trial Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Those who have been informed of the nature of the trial and have voluntarily agreed to participate in this study and have signed an IRB approved consent before all screening tests
  • Healthy Korean male and female volunteers aged 20 to 45
  • Those with a body weight of 50 kg or more and less than 90 kg and a body mass index (BMI) of 18 or more and less than 27 (BMI(kg/m2) = body weight (kg)/{height(m)}2
  • CYP2C19 EM or PM

Exclusion Criteria:

  • Subjects with clinical evidence of significant respiratory, circulatory, renal, hepatic, endocrine, blood, neuropsychiatric, skeletal or other chronic diseases, alcohol or drug addiction
  • Subjects with a history of gastrointestinal disorders (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test drug
  • Those with a history of substance abuse within the last 2 months
  • Those who have taken any prescribed medicines or herbal medicines within 2 weeks prior to the date of the first medicines, or those taking any general medicines (OTC) or vitamin preparations (eligible if the other conditions are reasonable according to the judgment of the investigator)
  • Those who donate blood within 30 days before the date of the first dose or who have participated in the clinical study of other clinical trial drugs or marketed drugs within 3 months
  • Those who have had significant adverse reactions such as hypersensitivity reactions to azole drugs including drugs for clinical research
  • Those who are not planning on or planning to have a pregnancy during the trial and are not able to use a recognized method of contraception (eg, sterilization surgery of the person and partner, intrauterine contraceptive device, or diaphragm contraception (such as diaphragm or condom use)
  • Persons who are continuously drinking (21 units / week, 1 unit = 10 g of pure alcohol) or who can not abstain from 3 days before the first dose to the end of the clinical trial
  • Those who smoked more than 10 cigarettes per day for the last 3 months or who can not quit smoking 3 days before the first dose
  • Those who consume grapefruit / caffeine-containing food within 3 days of the first dose or who cannot be prohibited during the clinical study period
  • Screening tests for urine pregnancy (β-hCG) positive or lactating women
  • Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • A person who is found to be unsuitable for participation in clinical research due to safety laboratory results or other reasons

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Voriconazole TBD mg tablet orally, every 12 hours for 7 days
To be determined mg of Voriconazole (Vfend®, anti-fungal agent)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Peak plasma concentration (Cmax)
大体时间:Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast)
大体时间:Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours

次要结果测量

结果测量
措施说明
大体时间
Genetic polymorphisms of CYP2C9 and CYP3A4
大体时间:Day 1 0 hour
Exploratory evaluation
Day 1 0 hour
Hepatic safety marker of miRNA-122
大体时间:Day 1 0 hour, Day 5 12 hour, Day 7 12 hour
Exploratory safety evaluation
Day 1 0 hour, Day 5 12 hour, Day 7 12 hour
Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
Physical examination (list of current medications)
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
Physical examination (list of any symptoms or pain)
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
Physical examination (Medical and surgical history)
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
Evaluation of Vital signs (body temperature °C)
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
Evaluation of Vital signs (blood pressure mmHg)
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
Evaluation of Vital signs (pulse (heart rate, beats per minute))
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
Safety and tolerability evaluation by 12-lead ECG (P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval, U wave)
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12
number of participants with abnormal laboratory values (hematologic, chemical, urine)
大体时间:Day 1 to Day 12
Safety and tolerability evaluation
Day 1 to Day 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年8月20日

初级完成 (实际的)

2018年10月28日

研究完成 (实际的)

2018年10月28日

研究注册日期

首次提交

2018年11月23日

首先提交符合 QC 标准的

2018年11月29日

首次发布 (实际的)

2018年11月30日

研究记录更新

最后更新发布 (实际的)

2018年11月30日

上次提交的符合 QC 标准的更新

2018年11月29日

最后验证

2018年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Voriconazole Oral Product (Vfend®)的临床试验

3
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