Effects of Renal Impairment on the Pharmacokinetics and Safety of Udenafil

Autor: Sangmin Choe, Sang Heon Cho, Sang Koo Lee, Won Seok Yang, Mi Young Bahng, Jai Won Chang, Yook Hwan Noh, Yong Soon Cho, Jong Lyul Ghim, Jung Sik Park, Soon Bae Kim, Hyeong Seok Lim, Kyun-Seop Bae
Rok vydání: 2018
Předmět:
Zdroj: The Journal of Clinical Pharmacology. 58:905-912
ISSN: 0091-2700
Popis: 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 (
Databáze: OpenAIRE