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

NCT00767598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2008-10-07

No results posted yet for this study

Summary

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.

Conditions

  • Pharmacokinetics of Three PDE5Is
  • Healthy Subjects
  • Genetic Polymorphic CYP3A5

Interventions

DRUG

phosphodiesterase type 5 inhibitor

single oral administration of 20mg vardenafil

DRUG

phosphodiesterase type 5 inhibitor

single oral administration of 100mg sildenafil

DRUG

phosphodiesterase type 5 inhibitor

single oral administration of 200mg udenafil

Sponsors & Collaborators

  • Inje University

    lead OTHER

Principal Investigators

  • Jae-Gook Shin · Inje University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2007-12-31
Completion
2008-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00767598 on ClinicalTrials.gov