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A Randomized, Open-Label, Parallel Group, Drug-drug Interaction Study to Evaluate the Effect of Fluconazole and Itraconazole on the Pharmacokinetics of Erdafitinib in Healthy Adult Subjects

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Trial Profile

A Randomized, Open-Label, Parallel Group, Drug-drug Interaction Study to Evaluate the Effect of Fluconazole and Itraconazole on the Pharmacokinetics of Erdafitinib in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Erdafitinib (Primary) ; Fluconazole; Itraconazole
  • Indications Breast cancer; Cholangiocarcinoma; Gastric cancer; Liver cancer; Lymphoma; Multiple myeloma; Non-small cell lung cancer; Oesophageal cancer; Solid tumours; Urogenital cancer
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 31 Oct 2019 Results published in the European Journal of Drug Metabolism and Pharmacokinetics
    • 10 Oct 2019 Results of a cross-study analysis of total 7 studies(NCT01703481,NCT02218073,NCT02231489,EuDRACT-2015-001583-19,NCT02692677,NCT03066687and NCT03135106) published in the Journal of Clinical Pharmacology
    • 20 Sep 2017 Status changed from recruiting to completed.

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