An Open Label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of Sorafenib Tablet for Oral Suspension Compared to Marketed Tablet and to Investigate the Pharmacokinetics of Sorafenib Tablet for Oral Suspension Including Food Effect and Dose Proportionality

Trial Profile

An Open Label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of Sorafenib Tablet for Oral Suspension Compared to Marketed Tablet and to Investigate the Pharmacokinetics of Sorafenib Tablet for Oral Suspension Including Food Effect and Dose Proportionality

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Sep 2017

At a glance

  • Drugs Sorafenib (Primary)
  • Indications Acute myeloid leukaemia; Acute promyelocytic leukaemia; Chronic lymphocytic leukaemia; Gastric cancer; Head and neck cancer; Liver cancer; Myelodysplastic syndromes; Neuroendocrine tumours; Ovarian cancer; Renal cancer; Soft tissue sarcoma; Thyroid cancer
  • Focus Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 01 Sep 2017 Results assessing relative bioavailability of Sorafenib tablet for oral suspension compared to marketed tablet and to investigate the pharmacokinetics of Sorafenib tablet for oral suspension including food effect and dose proportionality, were published in the Clinical Pharmacology in Drug Development Conference: 2017 Annual Meeting of the American College of Clinical Pharmacology, ACCP 2017.
    • 03 Aug 2016 Status changed from active, no longer recruiting to completed.
    • 11 Mar 2016 Planned End Date changed from 1 Apr 2016 to 1 May 2016 as reported by ClinicalTrials.gov record.
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