Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients (DA8159_RI_I)

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Kidney Diseases; Renal Insufficiency; Urologic Diseases

Treatments: Drug: Udenafil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01231997

2006-0431

Details and patient eligibility

About

This study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.

Enrollment: 27 estimated patients

Sex: Male

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult males aged 19 to 64 years at screening.
• Subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
• Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion criteria

• Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
• Subjects with hypotension or hypertension.
• Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
• Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

Healthy Volunteers

Experimental group

Treatment:

Drug: Udenafil

Patients with mild renal impairment

Experimental group

Treatment:

Drug: Udenafil

Patients with moderate renal impairment

Experimental group

Treatment:

Drug: Udenafil

Patients with severe renal impairment

Experimental group

Treatment:

Drug: Udenafil