NCT00901823撤回1 期
A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy VolunteersVOLUNTEERS
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR
研究概览
简要总结
This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Healthy adults
- •Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
- •Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL
排除标准
- •Known CAD, DM, uncontrolled HTN
- •Pregnancy or unable to complaint with the birth control method required
研究组 & 干预措施
Sequence 1
Experimental
Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR
干预措施: Diazoxide choline (Drug)
Sequence 2
Experimental
Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR
干预措施: Diazoxide choline high dose (Drug)
结局指标
主要结局
Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR
时间窗: 35 days
次要结局
- Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions(35 days)
研究者
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