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Pharmacokinetic drug interaction and safety after coadministration of clarithromycin, amoxicillin, and ilaprazole: a randomised, open-label, one-way crossover, two parallel sequences study

 Byung Hak Jin  ;  Byung Won Yoo  ;  Jungsin Park  ;  Jung Hye Kim  ;  Jun Yeon Lee  ;  Jae Soo Shin  ;  Min Soo Park 
 European Journal of Clinical Pharmacology, Vol.74(9) : 1149-1157, 2018 
Journal Title
 European Journal of Clinical Pharmacology 
Issue Date
2-Pyridinylmethylsulfinylbenzimidazoles/administration & dosage ; 2-Pyridinylmethylsulfinylbenzimidazoles/adverse effects ; 2-Pyridinylmethylsulfinylbenzimidazoles/blood ; 2-Pyridinylmethylsulfinylbenzimidazoles/pharmacokinetics* ; Adult ; Amoxicillin/administration & dosage ; Amoxicillin/adverse effects ; Amoxicillin/blood ; Amoxicillin/pharmacokinetics* ; Anti-Bacterial Agents/administration & dosage ; Anti-Bacterial Agents/adverse effects ; Anti-Bacterial Agents/blood ; Anti-Bacterial Agents/pharmacokinetics* ; Clarithromycin/administration & dosage ; Clarithromycin/adverse effects ; Clarithromycin/blood ; Clarithromycin/pharmacokinetics* ; Cross-Over Studies ; Drug Interactions ; Drug Therapy, Combination ; Healthy Volunteers ; Helicobacter Infections/drug therapy ; Helicobacter Infections/microbiology ; Helicobacter pylori/drug effects ; Humans ; Male ; Middle Aged ; Patient Safety ; Proton Pump Inhibitors/administration & dosage ; Proton Pump Inhibitors/adverse effects ; Proton Pump Inhibitors/blood ; Proton Pump Inhibitors/pharmacokinetics* ; Republic of Korea ; Risk Assessment ; Young Adult
Amoxicillin ; Clarithromycin ; Drug interaction ; Ilaprazole ; Pharmacokinetics ; Proton pump inhibitor
PURPOSE: Ilaprazole, the latest proton pump inhibitor, can be used with clarithromycin and amoxicillin as a triple therapy regimen for eradicating Helicobacter pylori. The aim of this study was to evaluate pharmacokinetic drug interactions and safety profiles after coadministration of clarithromycin, amoxicillin, and ilaprazole. METHODS: A randomised, open-label, one-way crossover, two parallel sequences study was conducted in 32 healthy subjects. In part 1, the subjects received a single dose of ilaprazole 10 mg in period 1 and clarithromycin 500 mg and amoxicillin 1000 mg twice daily for 6 days in period 2. In part 2, the subjects received clarithromycin 500 mg and amoxicillin 1000 mg once in period 1 and ilaprazole 10 mg twice daily for 6 days in period 2. In both sequences, the three drugs were coadministrated once on day 5 in period 2. Pharmacokinetic evaluations of ilaprazole (part 1), and clarithromycin and amoxicillin (part 2) were conducted. RESULTS: Twenty-eight subjects completed the study. For ilaprazole, the peak concentration (Cmax) slightly decreased from 479 (ilaprazole alone) to 446 ng/mL (triple therapy) [Geometric least square mean ratio (90% confidence interval), 0.93 (0.70-1.22)]. The area under the concentration-time curve from 0 h to the last measurable concentration (AUClast) slightly increased from 3301 to 3538 μg·h/mL [1.07 (0.85-1.35)]. For clarithromycin, the Cmax slightly decreased from 1.87 to 1.72 μg/mL [0.90 (0.70-1.15)], and AUClast slightly increased from 14.6 to 16.5 μg·h/mL [1.09 (0.87-1.37)]. For amoxicillin, the Cmax slightly decreased from 9.37 to 8.14 μg/mL [0.86 (0.74-1.01)], and AUClast slightly decreased from 27.9 to 26.7 μg·h/mL [0.98 (0.83-1.16)]. These changes in the PK parameters of each drug were not statistically significant. CONCLUSIONS: The coadministration of ilaprazole, clarithromycin, and amoxicillin was tolerable and did not cause a significant PK drug interaction. Thus, a triple therapy regimen comprising ilaprazole, clarithromycin, and amoxicillin may be an option for the eradication of H. pylori. Clinicaltrials.gov number: NCT02998437.
Appears in Collections:
2. College of Dentistry (치과대학) > Others (기타) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
류병원(Yoo, Byung Won) ORCID logo https://orcid.org/0000-0001-6895-1484
박민수(Park, Min Soo) ORCID logo https://orcid.org/0000-0002-4395-9938
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