Overview

A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Status:
Completed

Trial end date:
2011-02-01

Target enrollment:

Participant gender:

Summary

The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.

Phase:

Phase 1

Details

Lead Sponsor:

Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatments:

Citric Acid
Sildenafil Citrate
Sodium Citrate