NCT02253342已完成1 期
A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM)
研究概览
简要总结
This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males or females, 18 to 55 years of age (both inclusive) at the time of screening.
- •Medical history without any major pathology as judged by the Principal Investigator.
排除标准
- •History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •Positive urine drug/alcohol testing at screening or confinement.
- •Positive testing for HIV, Hepatitis B or Hepatitis C.
- •History or presence of alcohol or drug abuse within the 2 years prior to screening.
- •Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine) in the last 6 months prior to screening.
- •Known hypersensitivity to quinolones/fluoroquinolones.
- •History of allergic or other serious adverse reactions to benzodiazepines or lidocaine.
研究组 & 干预措施
WCK 2349
Experimental
Subjects will receive oral doses of WCK 2349 administered twice-daily for five days starting on Day 1
干预措施: WCK-2349 (Drug)
结局指标
主要结局
Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM)
时间窗: 5 days
Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349
次要结局
- Steady-state plasma pharmacokinetics of levonadifloxacin(5 days)
- Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign(14 days)
研究者
研究点 (1)
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