drugset / Trial / NCT01095601

Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects

NCT01095601

Phase 1 Completed 24 enrolled VIVUS LLC
RandomizedCrossoverOpen-labelPrevention

Summary

This study will assess the effect of food on the pharmacokinetics of avanafil (Formulation II); determine the relative bioavailability of two avanafil tablet formulations (Formulation I versus Formulation II) and will investigate the dose-proportionality of Formulation II avanafil tablet.

Timeline

Start
2010-04
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Avanafil Small molecule 50 mg Oral
Subject Avanafil Small molecule 200 mg Oral

Indications

No indication recorded.