NCT03760276已完成1 期
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
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
- 11
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Voriconazole TBD mg tablet orally, every 12 hours for 7 days
Experimental
干预措施: Voriconazole Oral Product (Vfend®) (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax)
时间窗: 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
Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast)
时间窗: 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
次要结局
- Genetic polymorphisms of CYP2C9 and CYP3A4(Day 1 0 hour)
- Hepatic safety marker of miRNA-122(Day 1 0 hour, Day 5 12 hour, Day 7 12 hour)
- Physical examination (list of current medications)(Day 1 to Day 12)
- Physical examination (list of any symptoms or pain)(Day 1 to Day 12)
- Evaluation of Vital signs (body temperature °C)(Day 1 to Day 12)
- Evaluation of Vital signs (blood pressure mmHg)(Day 1 to Day 12)
- Evaluation of Vital signs (pulse (heart rate, beats per minute))(Day 1 to Day 12)
- Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))(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)(Day 1 to Day 12)
- Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)(Day 1 to Day 12)
- Physical examination (Medical and surgical history)(Day 1 to Day 12)
- number of participants with abnormal laboratory values (hematologic, chemical, urine)(Day 1 to Day 12)
研究者
SeungHwan Lee
Clinical Assistant Professor
Seoul National University Hospital
研究点 (1)
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