Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers

Phase 1 Completed 115 enrolled Seoul Pharma Co., Ltd.

RandomizedCrossoverOpen-labelTreatment

Summary

This study investigates safety and pharmacokinetic comparison of Seoul Pharma's orally disintegrating film (ODF) formulation of sildenafil (test formulation) and Pfizer's "Viagra® (sildenafil)" Film Coated Tablet (FCT) formulation (reference formulation) in healthy volunteers.

Timeline

Start: 2011-09
Primary completion: 2011-11
Completion: 2011-12

Publications

Roh H, Son H, Lee D, Yeon KJ, Kim HS, Kim H, Park K. Pharmacokinetic comparison of an orally disintegrating film formulation with a film-coated tablet formulation of sildenafil in healthy Korean subjects: a randomized, open-label, single-dose, 2-period crossover study. Clin Ther. 2013 Mar;35(3):205-14. doi: 10.1016/j.clinthera.2013.02.006.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sildenafil	Unknown	50 mg	Oral
Subject	Sildenafil	Unknown	100 mg	Oral

Indications

No indication recorded.