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

Phase 2

Active, not recruiting

• Conditions: Gastro-intestinal effect; Oral health and wellness; Gastro-intestinal wellness; Alternative and Complementary Medicine - Other alternative and complementary medicine; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12613001348741
• Lead Sponsor: Manuka Health NZ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified