Effects of Renal Impairment on the Pharmacokinetics and Safety of Udenafil

Udenafil is a phosphodiesterase‐5 inhibitor used to treat erectile dysfunction. Although udenafil is not predominantly eliminated by the kidney, renal impairment can alter its secretion/transport pathways. Drug pharmacokinetics and safety must therefore be assessed in subjects with a renal impairment. We investigated the effects of impaired renal function on the pharmacokinetics and safety of a single 100‐mg oral dose of udenafil in a single‐dose, open‐label, parallel‐group study of 31 subjects. Cockcroft‐Gault creatinine clearance was used to stratify these subjects into healthy controls (>80 mL·min−1) and individuals with mild (50 to ≤80 mL·min−1), moderate (30 to ≤50 mL·min−1), and severe (