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An Open-label Study to Evaluate the Effect of Repeated Oral Administration of 200 mg Itraconazole(ITZ) Given Once Daily Over 14 Days on the Single Oral Dose Pharmacokinetics of Vilaprisan (BAY1002670) as Well as Assessment of Absolute Bioavailability Using a Single Intravenous Microtracer Dose of [14C]Vilaprisan in Healthy Postmenopausal Women

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Trial Profile

An Open-label Study to Evaluate the Effect of Repeated Oral Administration of 200 mg Itraconazole(ITZ) Given Once Daily Over 14 Days on the Single Oral Dose Pharmacokinetics of Vilaprisan (BAY1002670) as Well as Assessment of Absolute Bioavailability Using a Single Intravenous Microtracer Dose of [14C]Vilaprisan in Healthy Postmenopausal Women

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Vilaprisan (Primary) ; Itraconazole
  • Indications Endometriosis; Uterine leiomyoma
  • Focus Pharmacokinetics
  • Sponsors Bayer

    • Most Recent Events

    • 12 Jan 2018 Results assessing phamacokinetics of Vilaprisan in EudraCT2014-004929-41 and EudraCT2013-000707-16 studies, published in the Clinical Pharmacokinetics
    • 01 Mar 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 03 Feb 2016 Planned End Date changed from 1 Jan 2016 to 1 Feb 2016 as reported by ClinicalTrials.gov record.
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