Comparison of the pharmacokinetics and pharmacodynamics of YH4808 in healthy subjects for defining an appropriate dosing regimen
| العنوان: | Comparison of the pharmacokinetics and pharmacodynamics of YH4808 in healthy subjects for defining an appropriate dosing regimen |
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| المؤلفون: | Sukyong Yoon, Choon Ok Kim, Hyeonsoo Park, EunSil Oh, Hyun-Chul Kim, Min Soo Park, Seong Bok Jang, Hae Mi Byun |
| المصدر: | Translational and Clinical Pharmacology |
| بيانات النشر: | Korean Society for Clinical Pharmacology and Therapeutics, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, YH4808, business.industry, Ph control, Dosing regimen, Healthy subjects, Esomeprazole, Gastroenterology, Crossover study, Regimen, Pharmacokinetics, Pharmacodynamics, Internal medicine, medicine, Pharmacology (medical), Original Article, business, medicine.drug |
| الوصف: | YH4808 is a novel potassium-competitive acid blocker developed for gastric acid-related disorders. Previous studies indicate its potential to improve symptoms of gastric acid-related disorders. The current study was aimed to find the optimal regimen of YH4808 for night time pH control. This study was performed in two parts. Each was a randomized, open-label, active-controlled, multiple-doses, two-treatment, two-period crossover study conducted in 20 healthy Korean volunteers. Subjects were randomly assigned to one of the four groups. The three groups received different dosage regimens of YH4808 (100 mg twice a day, 200 mg once a day, or 200 mg twice a day), and the fourth group received esomeprazole 40 mg twice a day. The pharmacokinetic parameters demonstrated that the systemic exposure of YH4808 increased in a dose-proportional manner. The difference in the proportion of time above pH 4 over 24 h from the baseline was the greatest in the group receiving YH4808 200 mg twice a day. The values of the area under the effect curve at night time (12 A.M.-7 A.M.) were higher in all YH4808 groups than in the esomeprazole group. However, the differences among the YH4808 groups were not statistically significant (p > 0.05). YH4808 exhibited potential for better pH control during the night in comparison to esomeprazole. The optimal regimen for night time pH control among all the YH4808 regimens was 200 mg twice a day. Trial Registration ClinicalTrials.gov Identifier: NCT01761513. |
| اللغة: | English |
| تدمد: | 2383-5427 2289-0882 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2655829011b83c4b9e8e039e9670376b http://europepmc.org/articles/PMC8492394 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....2655829011b83c4b9e8e039e9670376b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 23835427 22890882 |
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