An Open Label, Single Dose, 2-Way, Randomized Cross-Over Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
研究概览
简要总结
The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.
详细描述
To support Linezolid NDA in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers.
- •18-40 years old, male.
- •BMI 19-24kg/m2.
排除标准
- •Alcohol, drug, smoke user.
- •Sensitive to oxazolidinones antibiotics class drug or heparin.
- •Severe medical or psychiatric condition or laboratory abnormality.
- •Blood donation.
- •12-ECG abnormal.
- •Treatment with study drug; clinically significant.
研究组 & 干预措施
Group 1
Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG.
干预措施: Linezolid (Drug)
Group 2
Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.
干预措施: Linezolid (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.
次要结局
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)](0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose)
- Terminal Half-Life (t1/2)(0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose)