NCT00942773已完成1 期
Clinical Trials to Evaluate the Influence of CYP2C19 Genotype and Drug-drug Interactions on the Pharmacokinetics of Voriconazole in Healthy Korean Male Volunteers (Part A)
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
- 18
- 试验地点
- 1
- 主要终点
- Plasma concentration of voriconazole
研究概览
简要总结
The purpose of this study is to:
- Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 20 - 50 years.
- •A body mass index (BMI) in the range 17-28 kg/m
- •Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
排除标准
- •Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
- •Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- •Presence or history of eye disease or eye field defect.
- •A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
- •A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
- •A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
- •Presence or history of drug abuse.
- •Participation in other clinical trial within 2 months.
- •Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
- •Blood donation during 2 months or apheresis during 1 month before the study.
- •Presence or history of alcohol abuse.
- •Smoking of more than 10 cigarettes/day.
- •Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
- •Subject judged not eligible for study participation by investigator.
研究组 & 干预措施
CYP2C19 extensive metabolizer
Active Comparator
干预措施: Voriconazole (Drug)
CYP2C19 heterozygous extensive metabolizer
Active Comparator
干预措施: Voriconazole (Drug)
CYP2C19 poor metabolizer
Active Comparator
干预措施: Voriconazole (Drug)
结局指标
主要结局
Plasma concentration of voriconazole
次要结局
- Adverse events collected by investigator questionnaire and subjects spontaneous report
- 12-lead ECG
- Clinical laboratory test
- Vital signs
研究者
研究点 (1)
Loading locations...
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