EUCTR2014-003306-33-NL进行中（未招募）1 期
iposomal amphotericin B (Ambisome) pharmacokinetics given as a single intravenous dose to obese patients (ASPEN). - ASPE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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.Patient has a BMI =40 kg/m2 and is undergoing bariatric surgery.
- •2.Subject is at least 18 years of age on the day of screening.
- •3.Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Documented history of sensitivity to medicinal products or excipients similar to polyene antifungal agents.
- •2.History of, or current abuse of drugs, alcohol or solvents (up until a maximum of three months before enrolment).
- •3.Inability to understand the nature of the trial and the procedures required.
- •4.Administration of nephrotoxic medication (aminoglycosids, immunosuppressants, antivirals, antineoplastic agents) up until a maximum of six months before enrolment.
研究者
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