A randomised, double-blind, placebo-controlled, parallel group, ascending multiple dose study to evaluate the tolerability of Manuka Honey with Honey CycloPowerTM chewable tablets taken daily by healthy subjects
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 NZ
48 participants
Sep 8, 2013
Interventional
Conditions
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multiple ascending dose study in healthy volunteers. Each subject will participate in one of 4 cohorts. Eligible subjects will receive a total daily dose (either as a single dose, twice daily or three (3) times a day) of Honey Cyclopower chewable tablets at 800mg to 4,800mg total daily dose, or the matching placebo. In each cohort, 8 subjects will receive Honey Cyclopower while 4 will receive matched placebo. The study will consist of a screening visit (Day -7 to -3), treatment period (Days 1 to 14) after which the final End of Study assessments will be completed. Once randomised, subjects will be given sufficient supplies for 7 days of treatment. After 7 days subjects will then return to the clinic where the subject will be assessed for safety and dosing compliance. Safety assessments will include physical examinations, vital signs, concomitant medications, adverse event and serious adverse event monitoring. If the tolerability is deemed acceptable, a second week of study treatment will be dispensed.
Eligibility
Inclusion Criteria6
- 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 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.
- Subjects must have a body mass index (BMI) within the range of 18 to 29 kg/m2 inclusive at screening.
- Subjects of childbearing potential must be using an acceptable method of contraception for the duration of the study.
- 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.
Exclusion Criteria9
- A past medical history of clinically significant disease or abnormality.
- Known allergy to any bee products or Honey Cyclopower
- Known allergies or intolerance to fibre-based products
- Known allergies or intolerance to xylitol or other ingredients in the study treatment
- 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 two (2) weeks prior to initial dosing in this study.
- Randomisation in a previous study evaluating Manuka Honey with CycloPower within 6 months of initial dosing in this study.
- Dosing of a study drug in any clinical investigation within 30 days prior to initial dosing in this study.
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Interventions
The purpose of this study is to evaluate safety and tolerability following the oral administration (sucking) of Manuka Honey with Cyclopower a day for 2 weeks. Cohort 1 will take 800mg (1 chewable tablet); Cohort 2 will take 1600mgs (2 tablets); cohort 3 will take 2400mgs (3 chewable tablets); cohort 4 will take 3200mgs (4 tablets); cohort 5 will take 4000mgs (5 tablets) and cohort 6 will take 4,800mg (6 chewable tablets), each cohort takes this amount daily in single or divided doses for 2 weeks (3 tablets 1x3 times daily; 4 tablets 2x2 daily; 5 tablets 2x2 plus 1x1 daily; 6 tablets 2x3 daily) . An exploratory assessment will also be completed to assess the potential benefits on oral health via saliva pH measurement. All unused tablets will be returned.
Locations(1)
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ACTRN12613001348741