A Randomized, Open-label, 2-Treatment Crossover Study to Compare by Scintigraphy, the Antireflux 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 Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pharmacodynamics: area under curve (AUC) of investigational medicinal product (IMP) percentage retention in the whole stomach
研究概览
简要总结
Primary Objective:
Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.
Secondary Objective:
Safety: assessment of the clinical safety of Z0063 versus Gaviscon Double Action tablets, in healthy adult subjects.
详细描述
The total study duration per subject is 37 days including a screening period up to 21 days, a wash-out period of 4-7 days and a follow-up of 4-7 days.
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: Z0063 (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: Gaviscon (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
Pharmacodynamics: area under curve (AUC) of investigational medicinal product (IMP) percentage retention in the whole stomach
时间窗: 4 hours after IMP administration
次要结局
- Pharmacodynamics: AUC of meal percentage retention in the whole stomach(4 hours after IMP administration)