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Open-label, Single-center Study in Healthy Subjects to Investigate the Effect of Oral Givinostat on Pharmacokinetics (PK) of Intravenous and Oral Midazolam and Oral Dabigatran Etexilate (PART 1)

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Trial Profile

Open-label, Single-center Study in Healthy Subjects to Investigate the Effect of Oral Givinostat on Pharmacokinetics (PK) of Intravenous and Oral Midazolam and Oral Dabigatran Etexilate (PART 1)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Jan 2025

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At a glance

  • Drugs Dabigatran etexilate (Primary) ; Givinostat (Primary) ; Midazolam (Primary) ; Midazolam (Primary)
  • Indications Duchenne muscular dystrophy; Myeloproliferative disorders; Polycythaemia vera
  • Focus Pharmacokinetics
  • Sponsors Italfarmaco

Most Recent Events

  • 06 Jan 2025 Protocol has been amended to include changes in treatment arms, endpoints, study design and patient number.
  • 06 Jan 2025 Protocol has been amended to include changes in treatment arms, endpoints, study design and patient number.
  • 12 Aug 2022 New trial record

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