잠시만 기다려 주세요. 로딩중입니다.

Pharmacodynamic evaluation of YH4808 for Helicobacter pylori eradication in healthy subjects

Translational and Clinical Pharmacology 2020년 28권 3호 p.136 ~ 146
박현수, 김춘옥, 김미경, 임예지, Lee Woo-Yul, Yoon Suk-Yong, 박민수,
소속 상세정보
박현수 ( Park Hyeon-Soo ) - Yonsei University College of Medicine Severance Hospital Department of Clinical Pharmacology
김춘옥 ( Kim Choon-Ok ) - Yonsei University College of Medicine Severance Hospital Department of Clinical Pharmacology
김미경 ( Kim Mi-Kyung ) - Yuhan Corporation
임예지 ( Lim Ye-Ji ) - Yuhan Corporation
 ( Lee Woo-Yul ) - Yonsei University College of Medicine Severance Hospital Department of Clinical Pharmacology
 ( Yoon Suk-Yong ) - Yonsei University College of Medicine Severance Hospital Department of Clinical Pharmacology
박민수 ( Park Min-Soo ) - Yonsei University College of Medicine Severance Hospital Department of Clinical Pharmacology

Abstract


YH4808 is a novel selective potassium-competitive acid blocker demonstrated to be safe and to have inhibitory effects against gastric acid secretion in previous studies. A randomized, open-label, multiple-dose, 3-treatment, 1-period, parallel design study was conducted to compare the Helicobacter pylori eradication rates and acid suppression capacities of three regimens in 60 healthy subjects with H. pylori-positive, and the potential of YH4808 to replace proton-pump inhibitors (PPIs) in standard regimens for H. pylori eradication. Group 1 received YH4808, amoxicillin, and clarithromycin as a novel triple regimen, while Group 2 received YH4808 and amoxicillin only, and Group 3 received esomeprazole, amoxicillin, and clarithromycin, as the standard triple regimen. H. pylori eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3. Relative response rate between Group 1 and 3 was 1.02 (0.50?2.07; 95% CI, χ2 test p = 0.8881). Furthermore, the novel triple regimen, YH4808, amoxicillin, and clarithromycin, stably inhibited acid secretion and maintained a gastric pH greater than 4 or 5 for 24 hours, which was comparable to the pH range in the standard triple regimen. However, the onset times of the YH4808 regimens were earlier than that for the regimens using esomeprazole. There were no differences in the incidences or severity of adverse events among the three groups. Overall, the novel triple regimen was safe and well-tolerated. YH4808 could replace PPIs in standard triple regimens used for H. pylori eradication.

키워드

YH4808; H. pylori; Esomeprazole; Pharmacodynamics

원문 및 링크아웃 정보

등재저널 정보