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A Single-dose, Open-label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules

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Trial Profile

A Single-dose, Open-label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Jul 2025

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At a glance

  • Drugs Zanubrutinib (Primary) ; Zanubrutinib
  • Indications B-cell lymphoma; Chronic lymphocytic leukaemia; CNS cancer; Diffuse large B cell lymphoma; Follicular lymphoma; Lupus nephritis; Lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; SARS-CoV-2 acute respiratory disease; Waldenstrom's macroglobulinaemia
  • Focus Pharmacokinetics
  • Sponsors BeiGene

Most Recent Events

  • 25 Jun 2025 According to BeOne Medicines Ltd media release, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA for all five approved indications.
  • 11 Jun 2025 According to BeOne Medicines Ltd media release, the company announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA (zanubrutinib) for all five approved indications.
  • 19 Jul 2023 Status changed from recruiting to completed.

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