A Randomized, Open Label, 2-Treatment Crossover Study to Compare by pH Metry, the Antacid Activity of the To-be-registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg Sodium Hydrogen Carbonate, Chewable Tablets) Versus the Registered Gaviscon Double Action Tablets, in Healthy Adult Subject
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of time at which the intragastric pH is at least equal to or greater than 4 during the 4-hour observation period post-dose
研究概览
简要总结
Primary Objective:
Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.
Secondary Objective:
Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in healthy adult subjects.
详细描述
The maximal total study duration per subject is 5 weeks and 1 day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
Sequence 1 (Z0063 to Gaviscon)
The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose
干预措施: Gaviscon (Drug)
Sequence 1 (Z0063 to Gaviscon)
The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose
干预措施: Z0063 (Drug)
Sequence 2 (Gaviscon to Z0063)
The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose
干预措施: Z0063 (Drug)
Sequence 2 (Gaviscon to Z0063)
The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose
干预措施: Gaviscon (Drug)
结局指标
主要结局
Percentage of time at which the intragastric pH is at least equal to or greater than 4 during the 4-hour observation period post-dose
时间窗: 4 hours after the investigational medicinal product (IMP) administration
次要结局
- Percentage of time at which the intragastric pH is at least equal to or greater than 3 during the 4-hour observation period post-dose(4 hours after the IMP administration)
- 4-hour median pH(4 hours after the IMP administration)