NCT00904748

A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate In Healthy Male Subjects, Fasting Dosing, Being The Test Formulation Sildenafil Citrate 100 Mg CT , And The Reference Formulation Sildenafil Citrate 100 Mg Film-Coated Tablets (Viagra®), Both Formulations Manufactured By Laboratórios Pfizer Ltda.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.

Detailed description

Bio-equivalence between two formulations of sildenafil citrate

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	sildenafil citrate 100 mg CT	sildenafil citrate 100 mg CT, single dose without water
DRUG	sildenafil citrate 100 mg CT	sildenafil citrate 100 mg CT, single dose with water
DRUG	Viagra®	sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-05-20
• Last updated: 2021-02-01
• Results posted: 2011-04-04

Locations

1 site across 1 country: Brazil