NCT01247805

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

A Pivotal Randomised, Open-Label 3-Way Crossover Study To Demonstrate Bioequivalence Of The Sildenafil Citrate Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil Citrate 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Arterial Hypertention

Interventions

Type	Name	Description
DRUG	sildenafil citrate	Single oral dose of 1 x 20 mg IR oral tablet.
DRUG	Sildenafil citrate	single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.
DRUG	sildenafil citrate	single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-11-24
• Last updated: 2021-02-02

Locations

1 site across 1 country: Belgium