NCT01080651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 B)
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
- 12
- 试验地点
- 1
- 主要终点
- Plasma concentration of voriconazole
研究概览
简要总结
To evaluate the drug-drug interaction between rifampicin and voriconazole according to CYP2C19 genotype quantitatively following a single oral administration of 200 mg 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
- •1.Healthy male subjects aged 20 - 50 years.
- •2.A body mass index (BMI) in the range 17-28 kg/m
- •3.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
- •1.Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
- •2.Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- •3.Presence or history of eye disease or eye field defect.
- •4.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.
- •5.A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
- •6.A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
- •7.Presence or history of drug abuse.
- •8.Participation in other clinical trial within 2 months.
- •9.Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
- •10.Blood donation during 2 months or apheresis during 1 month before the study.
- •11.Presence or history of alcohol abuse.
- •12.Smoking of more than 10 cigarettes/day.
- •13.Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
- •14.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 poor metabolizer
Active Comparator
干预措施: Voriconazole (Drug)
结局指标
主要结局
Plasma concentration of voriconazole
时间窗: pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h post-dose
Sample for concentration measurement conducted before and after rifampicin treatment as same manner
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Influence of CYP2C19 Genotype on Safety and Efficacy of Voriconazole in Pediatric Patients With Hematologic MalignancyAdverse Drug ReactionsNCT04743544Dokuz Eylul University62
已完成
1 期
Influence of CYP2C19 Polymorphism on PK/PD of OmeprazoleStomach UlcerNCT02299687Seoul National University Hospital24
Unknown
不适用
The Influence of CYP2C19 Polymorphisms on the Safety and Efficacy of VoriconazoleAdverse Drug ReactionsNCT04547335Dokuz Eylul University34
已完成
1 期
Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of VoriconazoleHealthyNCT00942773Seoul National University Hospital18
招募中
4 期
Comparative study of drug interaction with CYP2C19 substrate by Vonoprazan and Esomeprazole in healthy adultsoneJPRN-UMIN000029539Kameda Medical Center7