The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors in Male Subjects

In order to evaluate the effect of CYP3A5*3 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.

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Key information

Conditions

Pharmacokinetics of Three PDE5Is Genetic Polymorphic CYP3A5 Healthy Subjects

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

The aim of this study is to evaluate the different effect of the CYP3A5 genotype on the pharmacokinetics(PK) of sildenafil, udenafil, and vardenafil in healthy male subjects. Twenty one healthy male subjects with CYP3A5*1/*1, *1/*3, or *3/*3 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male subject whose CYP3A5 genotype was determined

Exclusion criteria

Subject whose CYP3A5 genotype was not determined

Treatment and study plan

phosphodiesterase type 5 inhibitor

Drug

single oral administration of 20mg vardenafil

Other names: vardenafil

Primary outcomes

Cmax, AUC

Time frame: upto 24hours

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects

Acronym: CYP3APDE5I

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2008
First posted: Oct 7, 2008
Registry last updated: Oct 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed