NCT00767598

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

The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Inje University · Academic / Other
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2007-12-01
• Completion: 2008-07-01
• First posted: 2008-10-07
• Last updated: 2008-10-07