NCT02335515Unknown早期 1 期
Gastric Retention Time of Floating Gastro-Retentive Capsules in Male Healthy Subjects After Breakfast as Measured by Magnetic Resonance Imaging (MRI)
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 15
- 主要终点
- To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast.
研究概览
简要总结
The primary objective of the study was to assess the gastric residence time (GRT) of the Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial screening visit. Eligible subjects will undergo the study procedure. The hypothesis is that the GRT of the Soctect Capsule after a standardized breakfast and lunch will be longer compared to literature values reported for a simliar sized capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male HS, aged between 18 and 50 years.
- •Subjects must be in a good health and have BMI between 19 and 25 kg/m
- •Subjects must be able to read, understand and sign the written informed consent.
- •Subjects must be willing and able to comply with study requirements.
排除标准
- •History of gastrointestinal, cardiorespiratory (including arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or alcohol abuse.
- •Subjects with a history of HIV, hepatitis B or hepatitis C.
- •Requiring medication that might alter gut function, including anticholinergics, calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump inhibitors and non-steroidal anti-inflammatory drugs.
- •Prior abdominal surgery other than uncomplicated appendectomy or hernia repair.
- •Subject with claustrophobia (fear of small spaces).
- •Presence of implants, devices or metallic foreign bodies that might interact with the MRI
- •Participation in another investigational study where the study drug was received within 90 days prior to the screening visit.
结局指标
主要结局
To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast.
时间窗: MRI scnas will be performed every 30 minutes starting after capsule intake for up to 12 hours
次要结局
未报告次要终点
研究者
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