Interaction Between Fluvoxamine and Sildenafil
Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males|
- Drug-induced changes of hand vein compliance
- Drug-induced changes of pharmacokinetic parameters
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||November 2004|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175981
|Dept. of Internal Medicine VI, University of Heidelberg|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Principal Investigator:||Walter E Haefeli, MD||Heidelberg University|