ACTRN12618000991213已完成1 期
A Multicentre, Randomised, Controlled, Observer-Blind Study to Evaluate Safety and Gastric Retention Properties of Modified Release Prototype Capsules in Healthy Adults
yndra Australia Pty Ltd.0 个研究点目标入组 40 人开始时间: 2018年6月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •1) Healthy male and female subjects
- •2) Body mass index of 18.0 to 30.0 kg/meters-squared
- •3) Suitable scores for two swallowing questionnaires
- •4) Demonstrate normal swallowing and gastrointestinal passage of capsules, as assessed while undergoing imaging studies
- •5) Must provide written informed consent
排除标准
- •1) Participants who have previously been enrolled in this study
- •2) History of any drug or alcohol abuse in the past 2 years
- •3) Current smokers and those who have smoked within the past 12 months
- •4) Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof
- •5) Individuals with a positive test for HIV, hepatitis B or hepatitis C
- •6) Serious adverse reaction or serious hypersensitivity to components of the study formulations or patency capsule
- •7) Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
- •8) Individuals with contraindication to MRI imaging
- •9) Individuals with functional constipation, irritable bowel, or functional diarrheoa, as evaluated by standardized questionnaire
- •10) Individuals with contraindications to elective X-ray based on known or expected radiation exposure
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