Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

Phase 1 Completed 36 enrolled Viatris Inc.

RandomizedCrossoverOpen-labelBasic science

Summary

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.

Timeline

Start: 2010-12
Primary completion: 2011-03
Completion: 2011-03

Outcome

Mixed primary results

paper Sildenafil ODT without water was bioequivalent to the marketed sildenafil film-coated oral tablet PMID 24447534 ↗

paper the 90% CI for sildenafil Cmax was not (79.76-92.78). PMID 24447534 ↗

Publications

Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sildenafil	Unknown	50 mg	Oral