Pharmacoscintigraphic study to evaluate two sildenafil products
Research type
Research Study
Full title
A pharmacoscintigraphic clinical study to evaluate a biphasic release sildenafil formulation (with immediate and sustained release components) compared to a marketed sildenafil product in fed and fasted states.
IRAS ID
233043
Contact name
Howard N.E. Stevens
Contact email
Sponsor organisation
N4 Pharma UK Ltd
Eudract number
2017-003959-34
Duration of Study in the UK
0 years, 1 months, 29 days
Research summary
This study will assess a new biphasic release sildenafil formulation, called N4S001 tablet developed by N4 Pharma UK Ltd. The N4S001 tablet contains a total of 100 mg sildenafil.
Biphasic means the drug will release in two stages: an immediate release layer will provide up to 20 mg of drug via sublingual administration (held under the tongue), and the remaining 80 mg of drug will be released via a sustained core tablet after the tablet is swallowed orally.
The N4S001 tablet is designed to provide a faster onset of drug release and a longer therapeutic window compared to products currently available on the market.
The release of the immediate layer of the N4S001 tablet will be investigated using gamma scintigraphy. We will compare the amount of drug in the bloodstream against a commercially available sildenafil product, Viagra 50 mg film-coated tablets. We will also ask study subjects to complete a taste acceptability 7-point categorical scale following administration of the N4S001 tablet.
This is a single centre, open label, four-arm cross over study in up to 12 healthy male volunteers. Subjects will receive one treatment at each visit. Treatments will be administered in both fed and fasted states, as follows:
Assessment Visit 1: N4S001 tablet containing 100 mg sildenafil (fasted)
Assessment Visit 2: N4S001 tablet containing 100 mg sildenafil (fed)
Assessment Visit 3: Viagra film coated tablet containing 50 mg sildenafil (fasted)
Assessment Visit 4: Viagra film coated tablet containing 50 mg sildenafil (fed)A radiolabel containing 4 MBq technetium-99m (99m-Tc) will be added to the outer layer of each N4S001 tablet to allow scintigraphic images to be taken using a gamma camera following dosing. The commercially available Viagra 50 mg tablets will not be radiolabelled. Blood samples will be taken throughout each assessment visit to measure the drug levels in the bloodstream.
REC name
Scotland A: Adults with Incapacity only
REC reference
17/SS/0123
Date of REC Opinion
8 Nov 2017
REC opinion
Favourable Opinion