ACTRN12613001206718尚未招募1 期
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MRX-I Tablets in Healthy Adult Subjects
CPR Pharma Services0 个研究点目标入组 30 人开始时间: 2013年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •This study will be conducted in normal, healthy, adult, male or female non-Chinese subjects aged between 18-50 years and with a BMI greater than or equal to 18 and less than or equal to 32. Eligible subjects will be in good health without signs or symptoms of current illness and with predose clinical and laboratory examinations without clinically significant findings.
排除标准
- •- History of any intolerance, hypersensitivity or allergic reaction to any oxazolidinone antibiotic
- •- History of bone marrow suppression or any type of anemia, leukopenia, thrombocytopenia, or pancytopenia
- •- History of peripheral or optic neuropathy
- •- History of hypoglycemia; low fasting glucose at screening (blood glucose level less than 50 mg/dL), even if normal upon repeat testing
- •- History of known or suspected serotonin syndrome, neuroleptic malignant syndrome, or carcinoid syndrome
- •- History of known or suspected lactic acidosis, unexplained acidosis, recurrent nausea and vomiting, or low bicarbonate levels associated with medication
- •- History of known or suspected Clostridium difficile-associated diarrhea
- •- Surgery or any acute illness within the past three months determined by the PI to be clinically relevant
- •- Females who are pregnant or nursing
研究者
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