NCT00950404

Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet

An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (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 bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Viagra 50 mg tablet	Commercial tablet, 50 mg, single dose administered with water
DRUG	Formulation B ODT tablet 50 mg	Oral disintegrating tablet (ODT), 50 mg, single dose administered without water
DRUG	Formulation C ODT tablet 50 mg	ODT, 50 mg, single dose administered without water
DRUG	Formulation D ODT tablet 50 mg	ODT, 50 mg, single dose, administered without water

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-07-31
• Last updated: 2021-02-01

Locations

1 site across 1 country: United States