Scintigraphy evaluation of colon targeted vitamin formulations
Research type
Research Study
Full title
A proof of concept scintigraphic study to investigate the in vivo performance of an orally delivered colon targeted vitamin formulation in healthy volunteers
IRAS ID
332044
Contact name
Laura Gow
Contact email
Sponsor organisation
BDD Pharma Ltd
Duration of Study in the UK
0 years, 1 months, 29 days
Research summary
This is a proof of concept, single centre study in up to 12 healthy male and female volunteers. The study is designed to assess the time and location of the release of a vitamin tablet designed to release in the colon. The vitamin tablet contains Vitamin C (220mg), Vitamin B2 (12mg), Vitamin B6 (2.5mg), Vitamin B3 (5.5mg), Vitamin B5 (6.7mg) and Vitamin B9 (10%) on Maltodextrin (5mg).
The primary purpose of this study is to demonstrate the site and time of onset of disintegration of the novel vitamin tablet formulation.
In 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 the tablet. The radioisotope to be used in this study is technetium-99m (99mTc).
Participants will attend a screening visit to confirm eligibility to take part in the study, one assessment visit where they will be dosed with one vitamin tablet and a follow up visit at the end of the study. Participants will attend the study centre fasted on the assessment visit and standardised meals will be provided at set times during the assessment visit.
REC name
West of Scotland REC 5
REC reference
23/WS/0127
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion