NL-OMON47120已完成4 期
iposomal amphotericin B (Ambisome) pharmacokinetics given as a single intravenous dose to obese patients (ASPEN). - ASPE
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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.
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 one month before enrolment.
研究者
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