Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products
Status:
Completed
Trial end date:
2018-06-13
Target enrollment:
Participant gender:
Summary
The study will assess a new biphasic release sildenafil formulation (N4S001), developed by N4
Pharma. The N4S001 tablet contains a total of 100 mg sildenafil.
The N4S001 tablet is designed to provide a faster onset of release and a longer therapeutic
window compared to currently marketed sildenafil products.
This is a single centre, open-label, four-arm crossover study in up to 12 healthy male
volunteers.
The following treatments will be dosed:
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)
The immediate release layer of each N4S001 tablet will be radiolabelled to contain 4 MBq
(megabecquerel) 99mTc at time of dose.