Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition

NCT01737203 Phase 1 COMPLETED

The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.

Details

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	53
Start date	2012-08
Completion	2012-09

Conditions

• Healthy

Interventions

• Viagra
• sildenafil ODT
• sildenafil ODT

Primary outcomes

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] — 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
• Maximum Observed Plasma Concentration (Cmax) — 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose

Countries

Japan