Pharmacoscintigraphic evaluation of three fexofenadine formulations
Research type
Research Study
Full title
A pharmacoscintigraphic evaluation of the performance of three novel fexofenadine hydrochloride formulations.
IRAS ID
271841
Contact name
Howard N.E. Stevens
Contact email
Sponsor organisation
BDD Pharma Ltd
Eudract number
2019-003947-31
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
This is a Phase I single centre, two part, open label, five treatment, crossover design in up to 24 healthy male subject (12 in part one and 12 in part two).\n\nIn Part One three prototype fexofenadine hydrochloride tablets will be investigated. Each prototype tablet releases 60 mg of fexofenadine hydrochloride immediately following dosing, with a further 120 mg of fexofenadine hydrochloride released after an approximately 6 hour delay. Two of the prototype tablets are designed to stay in the stomach until both doses are released. The third tablet is designed to release the first dose of drug in the stomach and release the second dose of drug in the colon. \n\nSubjects will also receive two marketed comparator products; a BID dose of Allegra 60 mg fexofenadine hydrochloride at one assessment visit with dosing separated by 12 hours (9am and 9pm) and a single dose of Telfast 180 mg fexofenadine hydrochloride tablet at one assessment visit.\n\nPart Two of the study is optional, dependent on the outcome of Part One. \n\nPart Two will be conducted in a further 12 healthy, male subjects (those enrolled in Phase One will be ineligible for Phase Two), and will comprise further pharmacoscintigraphic studies on one or more of the lead candidate prototype formulations selected from Phase One in fasted and/or fed states. Subjects may also receive one or both of the comparator products. Subjects in Part Two will be dosed with a maximum of five treatments.\n\nA radiolabel containing 4 MBq technitium-99m(99m-Tc)will be added to the prototype tablets to allow sequential scintigraphic images to be taken using a gamma camera following dosing. Blood samples will be drawn to allow measurements of drug levels in the bloodstream for the prototype and marketed comparator products.\n
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1708
Date of REC Opinion
12 Nov 2019
REC opinion
Favourable Opinion