Scintigraphic evaluation of colon targeted multivitamins tablets
Research type
Research Study
Full title
A pilot pharmacoscintigraphic study to investigate the localisation of release and uptake of a novel colon targeted vitamin formulation (ReBalance) compared to a conventional release vitamin formulation in healthy male volunteers
IRAS ID
302458
Contact name
Howard N.E. Stevens
Contact email
Sponsor organisation
BDD Pharma Ltd
Duration of Study in the UK
0 years, 2 months, 24 days
Research summary
This study is designed to confirm the localisation of release for the colon targeted dietary combination supplements known as ReBalance. The dietary supplements contains Vitamins C, B2, B3, B5, B6 and B9 and are designed to support health biome in the colon.\n\nThe following treatments will be dosed during the study:\n\nTreatment A: Radiolabelled Immediate release Rebalance vitamin tablet.\nTreatment B: Radiolabelled OralogiK Rebalance vitamin tablet\nTreatment C: Radiolabelled NutralogiK Rebalance vitamin tablet\n\nThe primary purpose of the study is to demonstrate the site and time of the release of OralogiK formulated vitamins compared to immediate release formulated vitamins. A NutralogiK formulation will also be assessed. This is the same technology as OralogiK but has been developed with food grade excipients for use in the dietary supplement market.\n\nIn this study we will use scintigraphic imaging to confirm the site of release in the gastrointestinal tract. To look at this parameter, we will add a small amount of radioactive materials to each tablet. Blood samples will also be taken with treatments A & B.\n\nSubjects will attend the unit fasted and standard meals will be provided at set times during Assessment Visits.\n\nSubjects will be required to attend the study unit on up to five occasions. \n
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0675
Date of REC Opinion
17 Oct 2021
REC opinion
Further Information Favourable Opinion