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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.
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.
Details
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2009-08 |
| Completion | 2009-09 |
Conditions
- Healthy Volunteers
Interventions
- Viagra 50 mg tablet
- Formulation B ODT tablet 50 mg
- Formulation C ODT tablet 50 mg
- Formulation D ODT tablet 50 mg
Primary outcomes
- AUC0-T and Cmax of sildenafil — 1 month
Countries
United States