Kidney Diseases, Renal Insufficiency, Urologic Diseases
Conditions
Keywords
SK-3530, renal impairment, healthy volunteers
Brief summary
This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.
Interventions
DRUGMirodenafil
50mg Single Oral Dose of
Sponsors
SK Chemicals 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 ≥ 50 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 deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (AUC and Cmax) | 2days |
Countries
South Korea
Outcome results
None listed