NL-OMON50389已完成不适用
A feasibility study investigating the safety, performance and gastrointestinal transit of the DV3395 device concept in healthy participants. - DV3395 device concept feasibility study.
ovo Nordisk0 个研究点目标入组 65 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1.Informed consent obtained before any study-related activities. Study-related
- •activities are any procedures that are carried out as part of the study,
- •including activities to determine suitability for the study.
- •2. Male or female.
- •3. Aged 18-55 years (both inclusive) at the time of signing informed consent.
- •4. Considered to be generally healthy based on the medical history, physical
- •examination, and the results of vital signs, electrocardiogram and clinical
- •laboratory tests performed during the screening visit, as judged by the
- •investigator.
- •5. Body mass index between 18.5 and 29.9 kg/m2 (both inclusive).
排除标准
- •1. Any disorder, which in the investigator*s opinion might jeopardise
- •participant*s safety or compliance with the protocol.
- •2. Presence of any known or suspected clinically significant GI disease or GI
- •disorder (including functional and structural disorders) as judged by the
- •investigator.
- •3. Presence of diarrhoea, defined as passage of three or more loose or liquid
- •stools per day (or more frequent passage than is normal for the individual)
- •within 14 days prior to screening or between screening and V2
- •pre-administration.
- •4. Presence of constipation (defined as having < 3 bowel movements per week,
- •hard stools, or any other stool-related issues according to ROME IV criteria
- •for functional constipation) within 14 days prior to screening or between
- •screening and V2 pre-administration.
- •5. History of clinically significant gastrointestinal or abdominal surgery
- •(including gynaecological/obstetrical and urological procedures) as judged by
- •the investigator.
- •Further criteria apply. See protocol.
研究者
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