Kidney Diseases, Renal Insufficiency, Urologic Diseases
Conditions
Keywords
Udenafil, DA-8159, renal impairment, healthy volunteers
Brief 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.
Interventions
DRUGUdenafil
100mg Single Oral Dose of
Sponsors
Dong-A Pharmaceutical Co., Ltd.
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (AUC and Cmax) | up to 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Safety | up to 48 hours |
Countries
South Korea
Outcome results
None listed