An Investigation into the Tolerability of Manuka Honey Cyclopower (Trademark) Chewable Tablets in Healthy Volunteers

Manuka Health NZ Ltd0 个研究点目标入组 32 人开始时间: 2013年12月10日最近更新: 2020年1月13日

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•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.
•Subjects must be non-smoking (no use of tobacco products in the previous 3 months).
•Subjects must have a body mass index (BMI) within the range of 18 to 29 kg/m2.
•Subjects of childbearing potential must be using an acceptable method of contraception for the duration of the study
•Subjects must be willing to omit the following dietary products from their diet during screening and throughout the study: dietary prebiotic fibre/ probiotic dietary products, probiotic yoghurt (such as Yakult, Activate), oral probiotics such as BLIS, laxatives / enhanced dietary fibre products (such as Metamucil)
•Subjects must be willing to omit the use of dental hygiene products the morning of saliva sample collection (randomisation and end of study) including brushing the teeth, use of mouth washes, antibacterial gum or lozenges.

•A past medical history of clinically significant disease or abnormality including illnesses which affect the gastrointestinal and immune systems
•Known allergy to any bee product or Honey Cyclopower
•Known allergies or intolerance to fibre-based products
•Known allergies or intolerance to xylitol or other ingredients in the study treatment
•Have poor oral health as determined by the presence of significant halitosis, active dental cavities or significant gingivitis
•Taken any antibiotics in the 3 months prior to screening
•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
•Use of any recreational drugs in last 7 days prior to initial dosing in this study
•Significant illness within 2 weeks prior to initial dosing in this study.
•Dosing of a study drug in any clinical investigation within 30 days prior to initial dosing in this study

发起方

Manuka Health NZ Ltd