NCT01737203

Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Viagra	50 mg tablet on Day 1 of each period
DRUG	sildenafil ODT	50 mg tablet on Day 1 of each period
DRUG	sildenafil ODT	50 mg tablet on Day 1 of each period

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-11-29
• Last updated: 2021-01-28

Locations

1 site across 1 country: Japan