The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors in Male Subjects - Full Text View

Sponsored by:	Inje University
Information provided by:	Inje University
ClinicalTrials.gov Identifier:	NCT00767598

Purpose

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.

Condition	Intervention	Phase
Pharmacokinetics of Three PDE5Is Healthy Subjects Genetic Polymorphic CYP3A5	Drug: phosphodiesterase type 5 inhibitor	Phase I

Drug Information available for: Sildenafil citrate Sildenafil Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects

Further study details as provided by Inje University:

Primary Outcome Measures:

Cmax, AUC [ Time Frame: upto 24hours ] [ Designated as safety issue: Yes ]

Enrollment:	21
Study Start Date:	December 2007
Study Completion Date:	July 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Vardenafil	Drug: phosphodiesterase type 5 inhibitor single oral administration of 20mg vardenafil
B: Active Comparator Sildenafil	Drug: phosphodiesterase type 5 inhibitor single oral administration of 100mg sildenafil
C: Active Comparator Udenafil	Drug: phosphodiesterase type 5 inhibitor single oral administration of 200mg udenafil

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male subject whose CYP3A5 genotype was determined

Exclusion Criteria:

Subject whose CYP3A5 genotype was not determined

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767598

Sponsors and Collaborators

Inje University

Investigators

Principal Investigator:

Jae-Gook Shin

Inje University

More Information

Responsible Party:	Inje University College of Medicine ( Department of Pharmacology and PharmacoGenomics Research Center )
Study ID Numbers:	07-109
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767598
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Inje University:

CYP3A5
sildenafil
udenafil
vardenafil

Study placed in the following topic categories:

Vardenafil
Sildenafil
Healthy

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009