pH telemetry and scintigraphy study on Risedronate tablets
Research type
Research Study
Full title
A Phase 1, single centre, open label, randomised, two-way crossover study in healthy volunteers using pH telemetry and scintigraphic imaging to compare Risedronate effervescent tablet against comparator Actonel Once Weekly
IRAS ID
305189
Contact name
Howard N.E. Stevens
Contact email
Sponsor organisation
Accord Healthcare
Eudract number
2021-004592-14
Duration of Study in the UK
0 years, 1 months, 12 days
Research summary
This study will assess the performance of a new Risedronate effervescent tablet containing 35mg risedronate (equivalent to 32.5mg risedronic acid) compared to the marketed product Actonel Once Weekly which also contains 35mg risedronate. The products are intended to treat osteoporosis.
The effervescent tablet is dissolved in water prior to consumption and Actonel Once Weekly is a solid tablet taken orally (by mouth) with water.
Up to 12 healthy female volunteers will take part in the study and they will each receive 1 x effervescent tablet and 1 x Actonel tablet.
In this study we will be looking at how each treatment affects the pH of the stomach by measuring gastric pH using a pH telemetry monitor. We will also use scintigraphic imaging to visualise the gastric emptying of the formulations (when they leave the stomach) and confirm the site of release (Actonel Once Weekly tablet only) in the gastrointestinal tract. To look at these parameters we will add a small amount of radioactive material to the Actonel Once Weekly tablet and to the water the effervescent tablet will be dissolved in for dosing.
REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0698
Date of REC Opinion
5 Nov 2021
REC opinion
Favourable Opinion