NCT01027117

A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers

A Randomised, Open-Label 3-Way Crossover Study To Investigate The Relative Bioavailability Of The Crushed Revatio 20 Mg Tablet Mixed With Apple Sauce, The Extemporaneously Prepared Suspension (EP), And The Intact Revatio 20 Mg Tablet In Healthy Volunteers Under Fasting Conditions

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

Summary

This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are: Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Revatio	Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
DRUG	Revatio	Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
DRUG	Revatio	Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-12-07
• Last updated: 2021-01-29

Locations

1 site across 1 country: Belgium