NCT00858325已完成1 期
A Two Cohort, Open Label, Single and Multiple Dose Pharmacokinetic Study of 4mg/Kg and 6mg/Kg Doses of Daptomycin in Healthy Chinese Subjects Living in China
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic data will be obtained from the analysis of blood and urine samples that will be obtained at specific time points throughout the study. The pharmacokinetic samples will be collected on days 1, 4 through 8 and 9.
研究概览
简要总结
The primary objective of this study is to characterise the pharmacokinetics and dose proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses of daptomycin in healthy Chinese volunteers.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women (not of childbearing potential) of Chinese ethnicity
- •Weight between 55Kg to 90Kg and have a Body Mass Index (BMI) between 18 and 25 kg/m2
- •Have a calculated creatinine clearance within range from 80 to 120 ml/min inclusive
排除标准
- •Unable to discontinue use of HMG-CoA reductase inhibitor therapy within 7 days prior to first dose of study drug through discharge from unit
- •CPK > 2X ULN (upper limit of normal)
结局指标
主要结局
Pharmacokinetic data will be obtained from the analysis of blood and urine samples that will be obtained at specific time points throughout the study. The pharmacokinetic samples will be collected on days 1, 4 through 8 and 9.
时间窗: On therapy evaluation on Day1~9.
次要结局
- Safety parameters (Incidence of AEs and SAEs, Deaths, Premature discontinuation due to an AE, regardless of relationship to study medication; Clinical lab data; Vital signs; ECG; Physical exam findings; Concomitant medications and adjunctive procedures).(On therapy evaluation on Day1~9.)
研究者
研究点 (1)
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