NCT00175981

Interaction Between Fluvoxamine and Sildenafil

Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (planned)
• Sponsor: Heidelberg University · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.

Detailed description

In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	sildenafil, fluvoxamine

Timeline

• Start date: 2003-02-01
• Completion: 2004-11-01
• First posted: 2005-09-15
• Last updated: 2005-09-15

Locations

1 site across 1 country: Germany