NCT02335515Unknown1 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
干预措施
试验速览
- 阶段
- 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.
研究组 & 干预措施
Soctec / Capsule
Experimental
HS intakes one(1) Soctec Capsule after standardized breakfast
干预措施: Soctec (Device)
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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