NCT01966055已完成1 期
A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents
研究概览
简要总结
A study of the safety and pharmacokinetics of solithromycin capsules in adolescents
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 to 17 yo male or female with suspected or confirmed bacterial infection
排除标准
- •Bacterial meningitis
- •Clinical significant concomitant medical condition
研究组 & 干预措施
Solithromycin
Experimental
干预措施: Solithromycin (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents
时间窗: 5 days
次要结局
未报告次要终点
研究者
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