NCT00400530已完成3 期
A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Gamma camera imaging of tablet dissolution in oesophagus
研究概览
简要总结
To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.
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
- Single
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal females aged greater 55 years
- •Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study
- •Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
- •Willing to abstain from smoking for 24 hours before each dose and until the end of each study day
排除标准
- •History of drug hypersensitivity
- •Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
结局指标
主要结局
Gamma camera imaging of tablet dissolution in oesophagus
次要结局
- Gamma camera dissolution of tablets in stomach
研究者
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