Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-10

AUTHORS

Eunwoo Kim, Anhye Kim, Sojeong Yi, Yu Kyong Kim, Seong Bok Jang, Hae Mi Byun, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu, SeungHwan Lee

ABSTRACT

PURPOSE: YH4808 is a potassium-competitive acid blocker, developed for the treatment of acid-related disorders. Two clinical studies in healthy male subjects were conducted to evaluate the effect of food on the pharmacokinetics of YH4808. METHODS: The first study, a randomized, three-treatment, three-period, crossover study, compared pharmacokinetics of YH4808 (300 mg) after a single dose at fed state with a standard or a high-fat meal to those at fasted state. The second study, a randomized, two-treatment, two-period, crossover study, investigated pharmacokinetics at fasted or fed state with a standard meal after twice daily dose of YH4808 (100 mg) for 7 days. Bloods for pharmacokinetic evaluation were sampled up to 48 h post-dose and 24 h post-dose at steady state, respectively. The pharmacokinetic parameters were estimated by non-compartmental method. RESULTS: After single dosing, the geometric means of maximum plasma concentration increased by 1.2 and 2.1 times in the fed states with a standard meal and a high-fat meal, respectively, of that in fasted state. Corresponding values of area under the plasma concentration-time curve (AUC) from time 0 to the last measurable time point increased by 1.8 and 2.8 times, respectively. After multiple dosing, the geometric mean for 24-h AUC at steady state slightly increased in fed state by 1.1 times of that in fasted state. CONCLUSIONS: As fat content of the food increased, the systemic exposure of YH4808 after single dosing increased. However, systemic exposures at steady state after multiple dosing between fasted and fed states were similar. TRIAL REGISTRATION: ClinicalTrials.gov registry no.: NCT01520012. More... »

PAGES

1261-1272

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00228-018-2502-9

DOI

http://dx.doi.org/10.1007/s00228-018-2502-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1104653480

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29907887


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