NCT03497715

Gamma Scintigraphy Study to Investigate Tablet Disintegration in Healthy Volunteers.

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 Liquid Capsules 2 x 200 mg and Two Reference Formulations of Ibuprofen Acid 2 x 200 mg in Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study will be an adaptive, 2 part, single dose, 5-way crossover gamma scintigraphy study in healthy subjects, to investigate the rate and site of tablet disintegration of various forms of Ibuprofen.

Detailed description

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and anti-pyretic properties. There are now a wide variety of formulations of ibuprofen available on market in which the active ingredient, ibuprofen, is either as the free acid, salt or salt in situ. As a result of differences between these formulations, differences in absorption and time to effectiveness are achieved. Rates of absorption are commonly assessed using pharmacokinetic (PK) studies, where the time taken for therapeutic plasma concentration levels to be reached can be determined, with associated absorption profiles being generated. Before absorption can occur the product must disintegrate in the stomach and empty into the small intestine. Gamma scintigraphy may be used to assess the disintegration rate (of tablets/capsules/caplets) by acquiring images of the investigational medicinal product (IMP) in vivo. Through the use of radiolabelled dosage forms, it enables the visualisation of key stages preceding absorption, including tablet disintegration and the rate of gastric emptying. The assessment of these stages, which are required prior to absorption in the small intestine, may be useful in gaining an understanding of the differences between the dosage forms. 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. The study will be conducted in two parts. Part 1 will be conducted as a pilot phase where each subject will receive all 5 IMPs over 5 treatment visits (one IMP/visit). The data generated in Part 1 will be assessed and used to determine whether to continue to Part 2 as planned, continue to Part 2 with adaptations or stop the study. Adaptations may involve altering the radiolabelling procedure and/or the gamma scintigraphy procedure and/or associated time-points and/or redefining primary/secondary endpoints and statistical analyses.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Ibuprofen lysine	Test 1
DRUG	Ibuprofen Sodium	Test 2
DRUG	Ibuprofen	Test 3
DRUG	Ibuprofen (Nurofen)	Reference 1
DRUG	Ibuprofen (Wockhardt)	Reference 2

Timeline

• Start date: 2015-04-14
• Primary completion: 2015-07-30
• Completion: 2015-07-30
• First posted: 2018-04-13
• Last updated: 2018-04-13