A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid
研究概览
简要总结
The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the oral formulations absorption and elimination from the healthy persons body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of or presence of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), or uncorrected hypokalemia or hypomagnesemia
- •Has a history of clostridium difficile-associated diarrhea
研究组 & 干预措施
Tedizolid Phosphate Oral Formulation 1 (Reference)
Participants will receive oral Formulation 1 (Reference).
干预措施: Tedizolid Phosphate Oral Formulation 1 (Reference) (Drug)
Tedizolid Phosphate Oral Formulation 2 (Test)
Participants will receive oral Formulation 2 (Test).
干预措施: Tedizolid Phosphate Oral Formulation 2 (Test) (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid
时间窗: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the AUC0-Inf of tedizolid.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid
时间窗: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the AUC0-Last of tedizolid.
Maximum Plasma Concentration (Cmax) of Tedizolid
时间窗: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the Cmax of tedizolid.
次要结局
- Number of Participants Who Experienced an Adverse Event (AE)(Up to approximately 2 weeks postdose)
- Number of Participants Who Discontinue Study Drug Due to an AE(Up to approximately 2 weeks postdose)
- Time to Maximum Plasma Concentration (Tmax) of Tedizolid(At designated time points (up to 3 days postdose))
- Apparent Terminal Half-Life (t1/2) of Tedizolid(At designated time points (up to 3 days postdose))
- Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F)(At designated time points (up to 3 days postdose))
- Apparent Clearance (CL/F) of Tedizolid(At designated time points (up to 3 days postdose))