Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products

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.

Timeline

Start

2018-05-08

Primary completion

2018-06-13

Completion

2018-06-13

Drugs

Indications