NCT02850718

A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: iX Biopharma Ltd. · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test sublingual sildenafil wafer.

Detailed description

Healthy volunteers will complete two inpatient study periods and receive either sublingual wafer sildenafil or oral sildenafil. Plasma samples and adverse events will be collected.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Sublingual Sildenafil	50 mg sildenafil sublingual wafer.
DRUG	Oral Sildenafil	50 mg oral sildenafil (Viagra)

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-08-01
• Last updated: 2016-08-19

Locations

1 site across 1 country: Australia