EUCTR2018-002579-16-SE进行中（未招募）1 期
Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus spp. related lung-disease. Part 1. Pharmacokinetic single center study.
Karolinska University Hospital, Stockholm CF center0 个研究点目标入组 12 人开始时间: 2018年7月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Confirmed diagnosis of cystic fibrosis
- •2. = 18 and < 65 years of age
- •3. Males and females
- •4. Clinically stable disease (but different pulmonary status)
- •5. Willing to participate in the study
- •6. Willing to use contraceptives
- •7. Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous adverse event on posaconazole
- •2. Ongoing treatment with posaconazol.
- •3. Advanced liver disease
- •4. Prolonged QTc-interval
- •5. Pregnancy, breastfeeding
- •6. Ongoing upper or lower respiratory infection requiring antibiotic treatment
- •7. Ongoing treatment with compounds contraindicated according to FASS
- •8. Ongoing or previous participation in a clinical pharmaceutical study within 28-days before screening.
- •9. Investigator assesses that it is not an appropriate study for the patient
研究者
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