Characterisation of Gastrointestinal Transit of Four New Developed Gel Matrix Tablets With Different Erosion Rates by Means of MMM Measurement Under Fasting and Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET)
研究概览
简要总结
The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix placebo tablets in healthy male volunteers under fasting and fed conditions. The method which is used is an imaging technique.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Ethnic origin: Caucasian
- •Body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
- •Good health
- •Written informed consent, after having been informed about benefits and potential risks of the trial
排除标准
- •Diseases which could influence the gastric emptying and gastrointestinal transport
- •Diet which could influence the gastric emptying and gastrointestinal transport
- •Surgery in the gastrointestinal tract which may interfere with the safety and transport of test product
- •Ferromagnetic implants or any other magnetic disturbance, which can affect the Magnetic Marker Monitoring measurement
- •Regular medical treatments which could affect the gastric emptying and gastrointestinal transport
研究组 & 干预措施
1
D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition
干预措施: D1000078 (Drug)
2
D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition
干预措施: D1000082 (Drug)
3
D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition
干预措施: D1000083 (Drug)
4
D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition
干预措施: D1000085 (Drug)
5
D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition
干预措施: D1000083 (Drug)
6
D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition
干预措施: D1000085 (Drug)
结局指标
主要结局
The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET)
The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT)
次要结局
未报告次要终点