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A Comparative, Proof of Concept Study, Comprising of a Pilot Phase Bioavailability Study Part and a Randomised, Cross-over Food-effect Study Part of 'XS003' and Originator in Healthy Male Subjects

Trial Profile

A Comparative, Proof of Concept Study, Comprising of a Pilot Phase Bioavailability Study Part and a Randomised, Cross-over Food-effect Study Part of 'XS003' and Originator in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2024

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At a glance

  • Drugs Nilotinib (Primary)
  • Indications Chronic myeloid leukaemia; Eosinophilia; Gastrointestinal stromal tumours; Malignant melanoma; Precursor cell lymphoblastic leukaemia-lymphoma; Skin cancer
  • Focus Pharmacokinetics; Proof of concept
  • Sponsors XSpray Microparticles; Xspray Pharma

Most Recent Events

  • 09 Jul 2024 According to a Xspray Pharma AB media release, company announced today new clinical data from its XS003 registration study program. In the announced study, XS003 demonstrates matching bioavailability to Tasigna, with a 50% reduced dose.
  • 09 Jul 2024 Results published in a Xspray Pharma AB media release
  • 10 Nov 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov

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