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

NCT ID: NCT00767598

Last Updated: 2008-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pharmacokinetics of Three PDE5Is Healthy Subjects Genetic Polymorphic CYP3A5

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Vardenafil

Group Type ACTIVE_COMPARATOR

phosphodiesterase type 5 inhibitor

Intervention Type DRUG

single oral administration of 20mg vardenafil

B

Sildenafil

Group Type ACTIVE_COMPARATOR

phosphodiesterase type 5 inhibitor

Intervention Type DRUG

single oral administration of 100mg sildenafil

C

Udenafil

Group Type ACTIVE_COMPARATOR

phosphodiesterase type 5 inhibitor

Intervention Type DRUG

single oral administration of 200mg udenafil

Interventions

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phosphodiesterase type 5 inhibitor

single oral administration of 20mg vardenafil

Intervention Type DRUG

phosphodiesterase type 5 inhibitor

single oral administration of 100mg sildenafil

Intervention Type DRUG

phosphodiesterase type 5 inhibitor

single oral administration of 200mg udenafil

Intervention Type DRUG

Other Intervention Names

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vardenafil sildenafil udenafil

Eligibility Criteria

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Inclusion Criteria

* Healthy male subject whose CYP3A5 genotype was determined

Exclusion Criteria

* Subject whose CYP3A5 genotype was not determined
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Inje University College of Medicine

Principal Investigators

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Jae-Gook Shin

Role: PRINCIPAL_INVESTIGATOR

Inje University

Other Identifiers

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07-109

Identifier Type: -

Identifier Source: org_study_id

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