Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175981
Status:
COMPLETED
Last Update Posted:
2005-09-15
First Post:
2005-09-09
Brief Title:
Interaction Between Fluvoxamine and Sildenafil
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 LCMS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None