Relative Bioavailability and Effect of Food on DSM265-TPGS 34% SDD Powder in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder formulation used in early clinical trials.
详细描述
The objective of this study is to compare the relative bioavailability of oral DSM265-TPGS 34% SDD formulation with that of a reference 25% SDD powder for suspension used in previous clinical trials. Another objective of the study is to evaluate the effect of food on bioavailability of the DSM265-TPGS 34% SDD formulation.
The current 25% SDD powder for suspension clinical formulation is a suspension which requires reconstitution/administration in 240 mL sucralose based vehicle (for a 400 mg adult dose). This volume is too large for paediatric patients with malaria (e.g., translates into a 30 mL volume for 0.5-2 yr old patients); also, the dosing vehicle is not commercially viable. The new formulation dissolves in a smaller volume of a more common vehicle, water (40 mL for 400 mg adult dose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DSM265-TPGS 34% SDD, 400 mg fasted
Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)
干预措施: DSM265-TPGS 34% SDD, 400 mg fasted (Drug)
DSM265-TPGS 34% SDD, 400 mg fed
Spray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)
干预措施: DSM265-TPGS 34% SDD, 400 mg fed (Drug)
DSM265 25% SDD, 400 mg fasted
Spray dried dispersion (SDD) formulation, powder containing 25% DSM265 as free base
干预措施: DSM265 25% SDD, 400 mg fasted (Drug)
结局指标
主要结局
Cmax
时间窗: 21 days
Maximum observed DSM265 plasma concentration
AUC168
时间窗: 168 hours
Area under the plasma concentration-time curve from time 0 to 168 hours (AUC168)
AUCt
时间窗: 21 days
AUC from time 0 until the last measurable concentration (AUCt),
C168
时间窗: 7 days
Plasma concentration at 168 hours
Tmax
时间窗: 21 days
Time to Cmax.
β
时间窗: 21 days
Apparent terminal phase elimination rate constant
次要结局
- AUCinf(21 days)