주메뉴 바로가기 본문 바로가기

아산 주요뉴스 모아보기

  • 2025년도 서울아산병원 임상약리학과 임상강사 모집 - 모집인원: 3명
    - 지원자격: 임상약리 전공의 과정 수료자, 타과 전문의 자격 소지자
    - 모집기간: 상시 모집 (~2025.08)
    자세히보기

닫기

논문/저서

논문/저서 상세페이지
Effects of Renal Impairment on the Pharmacokinetics and Safety of Udenafil.

J Clin Pharmacol. 2018 Jul;58(7):905-912. doi: 10.1002/jcph.1095. Epub 2018 Mar 14.

Effects of Renal Impairment on the Pharmacokinetics and Safety of Udenafil.

Cho YS, Noh YH, Lim HS, Cho SH, Ghim JL, Choe S, Kim SB, Park JS, Lee SK, Yang WS, Chang JW, Bahng MY, Bae KS.

 

Abstract

 

 

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 (<30 mL·min-1 ) renal impairment. Pharmacokinetic measurements and safety assessments indicated that the geometric mean of the area under the concentration-time curve to the last measurement in mildly, moderately, and severely renally impaired subjects was 1.30- (90% CI 1.05-1.60), 1.62- (90% CI 1.28-2.06), and 1.60- (90% CI 1.28-2.01) fold higher, respectively, than the healthy controls. The geometric mean of the maximum observed concentration was 1.41- (90% CI 1.05-1.88), 2.02- (90% CI 1.47-2.79), and 1.65- (90% CI: 1.21-2.24) fold higher, respectively. Significant correlations were observed among the creatinine clearance, oral clearance, and maximum concentration of udenafil (P < .01). All adverse events were mild, and no subject discontinued the study. Udenafil administration was well tolerated in all groups. In view of the clinical relevance of drug exposure, our findings indicate that a dose adjustment of udenafil is warranted in subjects with moderate or severe renal impairment.

 

PMID:

29537612 

DOI:

10.1002/jcph.1095

 

 

  • 현재 페이지를 인쇄하기
페이지 처음으로 이동
05505 서울특별시 송파구 올림픽로 43길 88 서울아산병원
TEL 1688-7575 webmaster@amc.seoul.kr
Copyright@2014 by Asan Medical Center. All Rights reserved.
  • 바로가기
  • 바로가기
  • 바로가기
  • 바로가기
  • 서울아산병원, 19년 연속 존경받는 병원 1위
  • 서울아산병원, 美 뉴스위크 평가 세계 22위·국내 1위
  • 서울아산병원, 정보보호 관리체계 ISMS 인증 획득