An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered Without Water Under Fed Compared To Fasted Conditions

NCT01254396 Phase 1 COMPLETED Results posted

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

Details

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2010-12
Completion	2011-01

Conditions

• Erectile Dysfunction

Interventions

• Sildenafil
• Sildenafil

Primary outcomes

• Maximum Observed Plasma Concentration (Cmax) — 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) — 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose
  Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).

Countries

Singapore