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
Abstract
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.
Conditions: Erectile Dysfunction.
Primary outcome: Sildenafil plasma concentrations.
Enrollment: 12 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.
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