A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.
研究概览
简要总结
This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
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 male and female subjects 18 to 75 years of age
- •Body mass index (BMI) between 22-35 kg/m2
- •Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.
- •Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL
- •Not pregnant
排除标准
- •Significant underlying medical conditions
- •Clinical laboratory test values outside the accepted range
- •Smokers, tobacco users, or subjects currently using nicotine products
- •Substance abuse
- •History of allergic response(s) to diazoxide or related drugs
- •Recent significant weight loss
- •Use of medication affecting body weight, lipid or glucose metabolism
- •Unable to comply with study procedures
研究组 & 干预措施
A
Diazoxide choline controlled-release coated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 9 through 16).
干预措施: Diazoxide choline (Drug)
B
Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release coated tablets administered orally once daily (Days 9 through 16)
干预措施: Diazoxide choline (Drug)
结局指标
主要结局
Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.
时间窗: 16 days
次要结局
- Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions(Study days 8 and 16)
- Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.(Entire study)