NCT00648869撤回不适用
Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).
研究概览
简要总结
Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design.
Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg & Metformin tablet 500mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men ranging in age from 18-40
- •Good general health as determined by medical history, physical examination, ECG, Blood pressure, and clinical laboratory tests (hematology & clinical chemistry) obtained within 14 days prior to the start of the study.
- •BMI >18&<
- •Willing and able to abide by the dietary requirements of the study.
- •Willing and able to give written informed consent in a manner approved by the Ethics Committee.
排除标准
- •History of known or suspected clinically significant hypersensitivity to any drug.
- •Any protocol-required laboratory test abnormality that is considered clinically significant.
- •Mentally unstable or incompetent.
- •Any illness during the week before.
结局指标
主要结局
To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).
时间窗: 45 days
次要结局
- To evaluate the effect on blood glucose levels as well as safety and tolerability of one time administration of the Metformin Gum and Metformin tablet.(45 days)
研究者
研究点 (2)
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