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    A Pharmacokinetic/Pharmacodynamic Study of Esomeprazole Comparing a Dual Delayed-Release Formulation (YYD601) to a Conventional Formulation Following Multiple Administrations in He... by Lee HW, Kang WY, Park JS, Lee JH, Park JJ, Gwon MR, Yoon YR, Seong SJ

    Published 2025-01-01
    “…Hae Won Lee,1 Woo Youl Kang,2 Ji Seo Park,1 Jae Hwa Lee,1 Jin Ju Park,1 Mi-Ri Gwon,1 Young-Ran Yoon,1 Sook Jin Seong1 1School of Medicine, Kyungpook National University and Department of Clinical Pharmacology and Therapeutics, Kyungpook National University Hospital, Daegu, 41944, Republic of Korea; 2Clinical Trial Dossier Evaluation Team, Innovative Products Support Department, National Institute of Food and Drug Safety Evaluation, Cheongju, 28159, Republic of KoreaCorrespondence: Young-Ran Yoon, Professor, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology and Therapeutics, Kyungpook National University Hospital, 130 Dongdeok-Ro, Jung-gu, Daegu, 41944, Republic of Korea, Tel +82-53-420-4950, +82-53-420-5218, Email yry@knu.ac.kr Sook Jin Seong, Clinical Associate Professor, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology and Therapeutics, Kyungpook National University Hospital, 130 Dongduk-Ro, Jung-gu, Daegu, 41944, Republic of Korea, Tel +82-53-200-6351, +82-53-420-5218, Email wintersj@knu.ac.krBackground: YYD601 is a new dual delayed-release formulation of esomeprazole, developed to enhance plasma exposure and prolong the duration of acid suppression.Purpose: This study aimed to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of YYD601 20 mg following single and multiple oral administrations in healthy, fasting adult Koreans, and to compare these outcomes to those of the conventional esomeprazole 20 mg capsule.Methods: A randomized, open-label, two-period crossover study was conducted in 28 participants, who were divided into two treatment groups: one group received YYD601 20 mg, and the other received conventional esomeprazole 20 mg, once daily for five consecutive days. …”
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