{
  "abstract": "Purpose\n\nZastaprazan is a novel potassium-competitive acid blocker with CYP3A-mediated metabolism, whereas atorvastatin undergoes CYP3A4- and transporter-mediated disposition. Because these drugs may be co-administered and their net interaction cannot be inferred from shared metabolic pathways alone, this study evaluated their steady-state pharmacokinetic drug-drug interaction.Participants and methods\n\nThis open-label, fixed-sequence, three-period, multiple-dose study included healthy Korean men. Participants received atorvastatin 40 mg once daily, zastaprazan 20 mg once daily, and concomitant atorvastatin and zastaprazan, each for 5 consecutive days, under steady-state conditions. Plasma concentrations of zastaprazan, atorvastatin, and 2-hydroxyatorvastatin were measured, and geometric mean ratios (GMRs) with 90% confidence intervals (CIs) were calculated for C max,ss and AUC τ,ss.Results\n\nTwenty-four healthy Korean men received at least one dose of a study drug, and 22 were included in the pharmacokinetic analysis. Atorvastatin decreased zastaprazan C max,ss by approximately 26% (GMR, 0.740; 90% CI, 0.655-0.836), whereas AUC τ,ss was preserved (GMR, 1.054; 90% CI, 0.927-1.198). Zastaprazan did not meaningfully alter atorvastatin exposure (C max,ss GMR, 0.982; 90% CI, 0.806-1.195; AUC τ,ss GMR, 1.029; 90% CI, 0.944-1.122). The AUC τ,ss of 2-hydroxyatorvastatin showed a modest decrease (GMR, 0.940; 90% CI, 0.889-0.994) that remained within the predefined conventional reference range. Co-administration was generally well tolerated, with no serious adverse events or adverse event-related discontinuations.Conclusion\n\nZastaprazan did not meaningfully alter atorvastatin C max,ss or AUC τ,ss under the studied conditions. Although atorvastatin reduced zastaprazan C max,ss, total exposure was preserved, a pattern consistent with altered absorption kinetics without establishing a specific mechanism. The pharmacodynamic significance of the lower zastaprazan C max,ss remains uncertain because intragastric pH was not measured. These pharmacokinetic findings do not suggest a need for atorvastatin dose adjustment under the studied conditions.",
  "abstract_shown": true,
  "affiliations": [
    "CHA Global Clinical Trial Center, CHA University Bundang Medical Center, Seongnam-si, Gyeonggi-do, Republic of Korea.",
    "Department of Physiology, CHA University School of Medicine, Pocheon, Gyeonggi-do, Republic of Korea.",
    "Department of Pharmacology, School of Medicine, CHA University, Seongnam-si, Gyeonggi-do, Republic of Korea.",
    "Department of Clinical Pharmacology and Therapeutics, CHA University Bundang Medical Center, Seongnam-si, Gyeonggi-do, Republic of Korea.",
    "Onconic Therapeutics Inc., Seoul, Republic of Korea."
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 6,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "A-Young Yang",
      "orcid": "0000-0002-2960-580X"
    },
    {
      "affs": [
        1
      ],
      "name": "Hongsock Kim"
    },
    {
      "affs": [
        0,
        2,
        3
      ],
      "name": "Hyounggyoon Yoo"
    },
    {
      "affs": [
        0,
        3
      ],
      "name": "Yil-Seob Lee"
    },
    {
      "affs": [
        4
      ],
      "name": "John Kim"
    },
    {
      "affs": [
        0,
        1,
        3
      ],
      "name": "Wonsuk Shin",
      "orcid": "0000-0002-6163-5726"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/7wfjd18dbewjt.bib",
  "cited_by": 0,
  "doi": "10.2147/dddt.s647170",
  "fulltext_url": "https://europepmc.org/articles/PMC13693804",
  "id": "7wfjd18dbewjt",
  "issns": [
    "1177-8881"
  ],
  "landing_url": "https://europepmc.org/article/MED/42921573",
  "language": "eng",
  "licence": "CC-BY-NC",
  "licence_label": "CC BY-NC",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "3004|Pharmacogenetics and Drug Metabolism"
    ]
  ],
  "openalex": "W7222879819",
  "pdf_url": "https://europepmc.org/articles/PMC13693804?pdf=render",
  "pmcid": "PMC13693804",
  "pmid": "42921573",
  "published": "2026-10-19",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/7wfjd18dbewjt.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:33Z",
      "native_id": "MED:42921573",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42921573"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3004|Pharmacogenetics and Drug Metabolism",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Steady-State Pharmacokinetic Drug-Drug Interaction Study of Zastaprazan, a Novel Potassium-Competitive Acid Blocker, and Atorvastatin in Healthy Participants.",
  "title_text": "Steady-State Pharmacokinetic Drug-Drug Interaction Study of Zastaprazan, a Novel Potassium-Competitive Acid Blocker, and Atorvastatin in Healthy Participants.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:33Z",
  "url": "https://research.draconitic.com/paper/7wfjd18dbewjt",
  "venue": "Drug design, development and therapy",
  "versions": []
}