NCT02396225终止不适用
Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Voriconazole concentration in serum
研究概览
简要总结
Concentrations of voriconazole in pulmonary epithelial lining fluid and in serum are compared after inhalation of 40 mg voriconazole b.i.d. for two days or oral intake of voriconazole tablets 400 mg bid for 1 day followed by 200 mg b.i.d. for one day, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned bronchoscopy in relation to work-up after hemoptysis or other symptom leading to bronchoscopy
- •Informed written consent
- •Performance status 0-1
- •Ct scan of thorax without suspicion of malignancy
- •Weight t ≥ 60 og ≤ 130 kg
- •Male gender or female gender in postmenopausal state defined by amenorrhea in more than 12 months.
排除标准
- •Voriconazole treatment up to one week before inclusion
- •Se-creatinin≥ 100 uM
- •ALAT ≥ 70 U/l
- •QT-interval > 480 ms
- •Allergic reaction to voriconazole or constituents in Vfend
- •Allergic reaction to other azoles
- •Ischemic Heart disease, Heart failure or uncontrolled hypertension
- •Treatment with statins or omeprazole, which cannot be paused for three days during voriconazole exposure
- •Treatment with Efavirenz, rifabutin, ritonavir, everolimus, methadon, alfentanil, fentanyl, sufentanil, oxycodone, hydrocodone, fluconazole, aztemizol, cisaprid, pimozid, quinidine, terfenadine, carbamazepine, phenobarbital, mephobarbital, ergotamine, dihydroergotamine, rifampicine, st. johns worth, everolimus, phenytoin, warfarin, phenprocoumon, acenocoumarol, benzodiazepines as midazolam, triazolam, alprazolam, sirolimus, cyclosporine, tacrolimus, ibuprofen, diclofenac,tolbutamide, glipizide, vincristine, vinblastine or other vinca alkaloids, HIV-protease Inhibitors e.g. saquinavir, amprenavir and nelfinavir, delavirdine, nivrapine and other non-nocleaoside revers transcriptase inhibitors
研究组 & 干预措施
Inhaled voriconazole
Experimental
12 patients inhale voriconazole 40 mg b.i.d for two days
干预措施: Voriconazole (Drug)
Oral Voriconazole
Active Comparator
12 patients ingest voriconazole tablets 400 mg b.i.d for one day followed by 200 mg b.i.d for one day
干预措施: Voriconazole (Drug)
结局指标
主要结局
Voriconazole concentration in serum
时间窗: 2 years
次要结局
- Voriconazole concentration in lunge epithelial lining fluid(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Therapeutic Drug Monitoring of VoriconazoleInvasive pulmonary aspergillosis.Invasive pulmonary aspergillosisB44.0IRCT20151227025726N19Shahid Beheshti University of Medical Sciences24
已完成
不适用
Voriconazole Blood Levels and ToxicityPharmacologyNCT00359541National Institute of Allergy and Infectious Diseases (NIAID)98
已完成
不适用
Bioavailability and Metabolism of Voriconazole in Relation to Its Modulation by the CYP2C19 Genetic PolymorphismHealthyNCT00175994Heidelberg University24
终止
不适用
Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic MalignancyInvasive Fungal InfectionNCT01148160Asan Medical Center10
已完成
4 期
Assessment of Target Site Pharmacokinetics of Voriconazole in Healthy Volunteers During Sequence TherapyHealthyNCT01539330Martin-Luther-Universität Halle-Wittenberg9