pH telemetry and scintigraphy study on Alendronate 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 Alendronate effervescent tablet against comparator Fosamax.
IRAS ID
299805
Contact name
Howard N.E. Stevens
Contact email
Sponsor organisation
Accord Healthcare
Eudract number
2021-002044-70
Duration of Study in the UK
0 years, 1 months, 9 days
Research summary
This study will assess the performance of a new Alendronate effervescent tablet containing 70mg alendronic acid compared to the marketed product Fosamax which also contains 70mg alendronic acid. The products are intended to treat osteoporosis.
The effervescent tablet is dissolved in water prior to consumption and Fosamax 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 Fosamax 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 (Fosamax tablet only) in the gastrointestinal tract. To look at these parameters we will add a small amount of radioactive material to the Fosamax tablet and to the water the effervescent tablet will be dissolved in for dosing.
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0390
Date of REC Opinion
28 Jun 2021
REC opinion
Further Information Favourable Opinion