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Evaluation of pharmacokinetic interactions between amoxicillin, clarithromycin, and the potassium-competitive acid blocker YH4808 in healthy subjects

Authors
 Woo Yul Lee  ;  EunSil Oh  ;  Mengqi Cui  ;  Choon Ok Kim  ;  Yeji Lim  ;  Hunam Kim  ;  Hyeonsoo Park  ;  Sukyong Yoon  ;  Min Soo Park  ;  Taegon Hong 
Citation
 Translational and Clinical Pharmacology, Vol.28(1) : 55-65, 2020-03 
Journal Title
 Translational and Clinical Pharmacology 
ISSN
 2289-0882 
Issue Date
2020-03
Keywords
Drug interactions ; Helicobacter pylori ; Pharmacokinetics ; Potassium-competitive acid blocker ; Triple therapy
Abstract
YH4808 is a novel potassium-competitive acid blocker that was developed as a therapeutic agent for gastric acid-related diseases; it may replace proton pump inhibitors, which are widely used in combination with amoxicillin and clarithromycin for Helicobacter pylori eradication. We compared the pharmacokinetic (PK) profiles and safety of amoxicillin, clarithromycin, and YH4808 used as monotherapies or in combination for evaluating potential drug interactions. An open-label, randomized, single-dose, Latin-square (4 × 4) crossover study was conducted in 32 healthy Korean volunteers. Subjects were randomly assigned to one of the 4 treatment sequences that consisted of 4 periods separated by 21-day washout intervals. PK parameters of YH4808, amoxicillin and clarithromycin administered in combination were compared with those of the respective monotherapies. The geometric mean ratios of the maximum concentration (Cmax) and the area under the time-concentration curve from time zero to time of the last quantifiable concentration (AUClast) of YH4808 increased during the triple therapy by 48.6% and 29.1%, respectively. Similarly, the Cmax and AUClast of M3 (active metabolite of YH4808) increased by 23.3% and 16.0%, respectively. The Cmax and AUClast of clarithromycin increased by 27.4% and 30.5%, and those of 14-hydroxyclarithromycin were increased by 23.1% and 32.4%, respectively. The corresponding amoxicillin values decreased during the triple therapy by 21.5% and 15.6%, respectively. There was no clinically significant change in safety assessment related to either monotherapies or triple therapy. In conclusion, amoxicillin, clarithromycin and YH4808 administered as triple therapy did not exhibit significant PK interactions and were not associated with safety issues.
Files in This Item:
T202002871.pdf Download
DOI
10.12793/tcp.2020.28.e5
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
7. Others (기타) > Others (기타) > 1. Journal Papers
Yonsei Authors
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
Hong, Tae Gon(홍태곤) ORCID logo https://orcid.org/0000-0001-7490-0085
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/179034
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