ACTRN12619000571178已完成1 期
Phase 1, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Memantine HCl and Donepezil HCl Extended Release Capsules in Healthy Volunteers
yndra Australia Pty Ltd0 个研究点目标入组 8 人开始时间: 2019年4月11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
- 8
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
- Non-randomised trial
- 主要目的
- Treatment
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 participants
- •2) Body mass index of 18.0 to 30.0 kg/meters-squared
- •3) Suitable score for swallowing questionnaire
- •4) Demonstrate normal swallowing and gastrointestinal passage for capsules, as assessed while undergoing imaging studies
- •5) Must provide written informed consent
排除标准
- •1) History of any drug or alcohol abuse in past 2 years
- •2) Current smokers and those who have smoked within the past 12 months
- •3) Individuals with clinically significant medical history related to the gastrointestinal tract and potential complications, thereof
- •4) Individuals with a positive test for HIV, hepatitis B or hepatitis C
- •5) Individuals who are contraindicated based on either memantine HCl or donepezil HCl
- •6) Serious adverse reaction or serious hypersensitivity to components of the study formulation 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 bowl or functional diarrhoea
- •10) Individuals with contraindications to elective X-ray based on known or expected radiation exposure
研究者
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