Gamma Scintigraphy Study to Investigate Tablet Disintegration
Research type
Research Study
Full title
A randomised, single dose, 5 way crossover, open-label adaptive design, gamma scintigraphy study comparing the disintegration profile of oral ibuprofen lysine 2 x 342 mg, ibuprofen sodium 2 x 256 mg, ibuprofen potassium 2 x 200 mg and two reference formulations of ibuprofen acid 2 x 200 mg in healthy volunteers.
IRAS ID
157737
Contact name
Girish Sharma
Contact email
Sponsor organisation
Reckitt Benckiser
Eudract number
2014-002721-35
Duration of Study in the UK
0 years, 3 months, 20 days
Research summary
The study is a 5 way crossover design, comparing 5 different formulations of ibuprofen in healthy males.
The main purpose of this study is to visualise and determine the rate of disintegration and subsequent availability for absorption of different ibuprofen formulations, by gamma scintigraphy. This will involve the comparison of three test ibuprofen formulations (ibuprofen lysine film-coated caplets 2 x 342 mg, ibuprofen sodium sugar-coated caplets 2 x 256 mg and ibuprofen liquid capsules (potassium in situ) 2 x 200 mg) with 2 reference formulations of ibuprofen (ibuprofen acid sugar-coated tablets 2 x 200 mg), in healthy subjects. One of the IMP formats will be radiolabelled with 5.5 MBq Technetium-99m [99mTc] in the form of 99mTc-dietheylene triamine pentaacetic acid (99mTc-DTPA), in a way which does not affect the disintegration properties of the IMP.
This study aims to support and complement a pharmacokinetic study (NL1307) with visualisation of the disintegration properties of the tablet and capsule in the stomach, using the same ibuprofen formulations. Furthermore understanding the disintegration characteristics of the 3 test products is vital, as this will aid future formulation development.
The study will consist of a screening period (21 days before first dose), a total of 5 treatment visits and lastly a post study visit (Within 7 days after treatment visit 5).
The study is separated into a pilot and a pivotal phase. The pilot will require 4 male volunteers, whilst the pivotal will require 26 males to be randomised.
The population who are eligible to take part in the study are healthy males aged between 18 and 50 years, as identified by screening tests at Simbec.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1365
Date of REC Opinion
27 Feb 2015
REC opinion
Further Information Favourable Opinion