Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects.
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...
| Published in: | European Journal of Clinical Pharmacology Vol. 74; no. 10; pp. 1261 - 1273 |
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| Main Authors: | , , , , , , , , , , |
| Format: | research tables/charts randomized controlled trial Journal Article |
| Published: |
Springer Nature
Oct2018
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=131720957&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 131720957 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Oct2018 vid: 74 iid: 10 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 131720957 131720957 131720957 10.1007/s00228-018-2502-9 131720957 ppf: 1261 ppct: 12 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects. aug: au: Kim, Eunwoo Kim, Anhye Yi, Sojeong Kim, Yu Kyong Jang, Seong Bok Byun, Hae Mi Yoon, Seo Hyun Cho, Joo-Youn Jang, In-Jin Yu, Kyung-Sang Lee, SeungHwan affil: Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea sug: subj: Antacids Pharmacokinetics Antacids Administration and Dosage Food Human Randomized Controlled Trials Crossover Design Dietary Fats Meals Fasting Antacids Blood ab: 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: <ext-link>ClinicalTrials.gov</ext-link> registry no.: NCT01520012 pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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