The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors in Male Subjects (CYP3APDE5I)

October 6, 2008 updated by: Inje University

The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subject whose CYP3A5 genotype was determined

Exclusion Criteria:

  • Subject whose CYP3A5 genotype was not determined

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Vardenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 20mg vardenafil
Other Names:
  • vardenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 100mg sildenafil
Other Names:
  • sildenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 200mg udenafil
Other Names:
  • udenafil
Active Comparator: B
Sildenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 20mg vardenafil
Other Names:
  • vardenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 100mg sildenafil
Other Names:
  • sildenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 200mg udenafil
Other Names:
  • udenafil
Active Comparator: C
Udenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 20mg vardenafil
Other Names:
  • vardenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 100mg sildenafil
Other Names:
  • sildenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 200mg udenafil
Other Names:
  • udenafil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax, AUC
Time Frame: upto 24hours
upto 24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Jae-Gook Shin, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2008

Last Update Submitted That Met QC Criteria

October 6, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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