CTRI/2012/01/002326已完成1 期
An open-label, single dose, crossover study to evaluate the relative bioavailability of a new fingolimod formulation (2Ã?0.25 mg) in comparison to the Final Market Image (FMI, 0.5 mg) in healthy volunteers.
ovartis Healthcare Private Limited0 个研究点目标入组 42 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Healthy subjects
- •2. Female subjects must be of non-child bearing potential
- •3. Subjects must weigh at least 50 kg and their BMI should be within range of 18-30 kg/m2
排除标准
- •1. Smokers
- •2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •3. Pregnant or nursing (lactating) women
- •4. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- •5. History of clinically significant ECG abnormalities, malignancy of any organ system, history of immunodeficiency diseases; of drug or alcohol abuse.
研究者
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