Ignite Creation Date:
2024-05-05 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00767598
Status:
COMPLETED
Last Update Posted:
2008-10-07
First Post:
2008-10-06
Brief Title:
The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors in Male Subjects
Sponsor:
Inje University
Organization:
Inje University
Study Overview
Official Title:
The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 InhibitorsPDE5I in Male Subjects
Status:
COMPLETED
Status Verified Date:
2008-07
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:
CYP3APDE5I
Brief Summary:
In order to evaluate the effect of CYP3A53 allele on the pharmacokinetics of sildenafil udenafil and vardenafil the clinical trial using a single oral dose was conducted in Korean healthy male subjects whose genotype of CYP3A5 had been determined
Detailed Description:
The aim of this study is to evaluate the different effect of the CYP3A5 genotype on the pharmacokineticsPK of sildenafil udenafil and vardenafil in healthy male subjects Twenty one healthy male subjects with CYP3A511 13 or 33 were enrolled An open-label 3-way crossover study was performed with a week washout A single oral dose of PDE5I 100 mg sildenafil 200 mg udenafil 20 mg vardenafil was administered respectively After a single oral dose of phosphodiesterase type 5 inhibitor PDE5I plasma levels of the parent and the major metabolite were measured up to 24 or 48 h
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