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

Kidney Diseases Clinical Trial

— DA8159_RI_I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231997
• Other study ID #: 2006-0431
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2010
• Last updated: November 1, 2010
• Start date: November 2009

Study information

• Verified date: October 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Urologic Diseases

Intervention

Drug:
• Udenafil
100mg Single Oral Dose of

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (AUC and Cmax)		up to 48 hours
Secondary	Safety		up to 48 hours

External Links

•   Clinical Research Center, Asan Medical Center