A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Tedizolid Phosphate Single Unit Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Multiple Dose Bottle Powder for Oral Suspension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 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 absorption and elimination of different oral formulations from the healthy person's 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 60 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:
- •Is in good health before randomization
- •Has a body mass index (BMI) ≥18.5 and ≤34 kg/m^2, inclusive
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Has a history of clinically significant cancer (malignancy)
研究组 & 干预措施
Tedizolid Phosphate Oral Formulation 1 (Reference)
Participants receive tedizolid phosphate formulation 1 orally.
干预措施: Tedizolid Phosphate Oral Formulation 1 (Reference) (Drug)
Tedizolid Phosphate Oral Formulation 2 (Test)
Participants receive tedizolid phosphate formulation 2 orally.
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 the Last Measurable Concentration (AUC0-t) of Tedizolid
时间窗: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the AUC0-t 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
- Apparent Volume of Distribution of Tedizolid After Nonintravenous Administration (Vd/F)(At designated time points (up to 3 days postdose))
- Oral Clearance (CL/F) of Tedizolid(At designated time points (up to 3 days postdose))
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 2 weeks)
- Number of Participants Who Discontinue Study Due to an AE(Up to approximately 2 weeks)
- 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))