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An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced Solid Tumors

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Trial Profile

An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced Solid Tumors

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Jul 2024

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At a glance

  • Drugs Niraparib (Primary) ; Niraparib
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Acronyms TABLET
  • Sponsors GlaxoSmithKline; GSK; TESARO
  • Most Recent Events

    • 12 Sep 2023 Results assessing the relative bioavailability(BA; Stage 1 [S1]) and bioequivalence (BE; Stage 2 [S2])between niraparib tablets and capsules, presented at the 2023 American College of Clinical Pharmacology Annual Meeting
    • 06 Jun 2023 Results assessing the relative bioavailability (BA; Stage 1 [S1]) and bioequivalence (BE; Stage 2 [S2]) between niraparib tablets and capsules, presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
    • 21 Jul 2022 Planned End Date changed from 16 Jun 2022 to 8 May 2023.
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