NCT01560143已完成4 期
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Manjunath Prakash Pai1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours
研究概览
简要总结
If tigecycline clearance increases with body size then serum exposure values will be lower in obese class III compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight.
详细描述
Not required
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects fulfilling the following criteria will be eligible:
- •males and females, 18 to 50 years of age;
- •non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
- •Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
- •female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period
排除标准
- •history of significant hypersensitivity reaction to any components of Tygacil®;
- •history of significant clinical illness requiring pharmacological management;
- •history of blood donation in the past eight week period;
- •abnormal serum electrolyte or complete blood count requiring further clinical work-up;
- •transaminases (AST or ALT) > 2.5 x upper limit of normal;
- •subjects with stage 4 or 5 chronic kidney disease;
- •positive serum pregnancy test (if female);
- •abnormal electrocardiogram (ECG) as judged by study physician;
- •unable to tolerate venipuncture and multiple blood draws;
- •clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up;
- •unable to independently provide a written informed consent.
研究组 & 干预措施
Tigecycline
Other
All subjects receive a single dose of tigecycline
干预措施: Tigecycline (Drug)
结局指标
主要结局
Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours
时间窗: 4 days (96 hours)
The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour\*mg/L)
次要结局
未报告次要终点
研究者
Manjunath Prakash Pai
Associate Professor
University of Michigan
研究点 (1)
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