ACTRN12613001348741进行中（未招募）2 期
A randomised, double-blind, placebo-controlled, parallel , ascending multiple dose study to evaluate the tolerability of Manuka Honey with Honey CycloPowerTM chewable tablets taken daily by healthy subjects
Manuka Health NZ0 个研究点目标入组 48 人开始时间: 2013年12月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1. Healthy subjects age 18 to 45 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs at screening.
- •2. Subjects must be non-smoking (no use of tobacco products in the previous 3 months).
- •3. Subjects must have had no active dental caries within the last 2 years of screening and be willing to avoid intake of food or beverages for at least 1 hour (for the collection of saliva samples) at randomisation and at the final visit.
- •4. Subjects must have a body mass index (BMI) within the range of 18 to 29 kg/m2 inclusive at screening.
- •5. Subjects of childbearing potential must be using an acceptable method of contraception for the duration of the study.
- •6. Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study and understand and sign the written informed consent.
排除标准
- •1. A past medical history of clinically significant disease or abnormality.
- •2. Known allergy to any bee products or Honey Cyclopower
- •3. Known allergies or intolerance to fibre-based products
- •4. Known allergies or intolerance to xylitol or other ingredients in the study treatment
- •5. Use of any prescription drugs within 7 days prior to initial dosing in this study, other than occasional use of analgesics (less than 3 days in any 7-day period) and/ or hormonal contraceptives
- •6. Use of any recreational drugs in last 7 days prior to initial dosing in this study
- •7. Significant illness within two (2) weeks prior to initial dosing in this study.
- •8. Randomisation in a previous study evaluating Manuka Honey with CycloPower within 6 months of initial dosing in this study.
- •9. Dosing of a study drug in any clinical investigation within 30 days prior to initial dosing in this study.
研究者
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