NCT00376324已完成1 期
An Open-Label, Multiple-Dose Study of the Pharmacokinetics of Tigecycline in Human Bone
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration.
研究概览
简要总结
Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and nonlactating and nonpregnant women greater than or equal to 18 years of age.
- •Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG).
- •Have a high probability for compliance with and completion of the study.
排除标准
- •Subjects with chronic osteomyelitis.
- •Subjects who have known or suspected hypersensitivity to tigecycline or other tetracyclines.
- •Involvement in other investigational studies of any type within 30 days before test article administration.
结局指标
主要结局
To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration.
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
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