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Trial record 39 of 93909 for:    5

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

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ClinicalTrials.gov Identifier: NCT00767598
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : October 7, 2008
Sponsor:
Information provided by:
Inje University

Brief 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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics of Three PDE5Is Healthy Subjects Genetic Polymorphic CYP3A5 Drug: phosphodiesterase type 5 inhibitor Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects
Study Start Date : December 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A
Vardenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 20mg vardenafil
Other Name: vardenafil

Active Comparator: B
Sildenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 100mg sildenafil
Other Name: sildenafil

Active Comparator: C
Udenafil
Drug: phosphodiesterase type 5 inhibitor
single oral administration of 200mg udenafil
Other Name: udenafil




Primary Outcome Measures :
  1. Cmax, AUC [ Time Frame: upto 24hours ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767598


Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Jae-Gook Shin Inje University

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Responsible Party: Department of Pharmacology and PharmacoGenomics Research Center, Inje University College of Medicine
ClinicalTrials.gov Identifier: NCT00767598     History of Changes
Other Study ID Numbers: 07-109
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: October 7, 2008
Last Verified: July 2008
Keywords provided by Inje University:
CYP3A5
sildenafil
udenafil
vardenafil
Additional relevant MeSH terms:
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Sildenafil Citrate
Vardenafil Dihydrochloride
Udenafil
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents