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A Single-Dose, Bioequivalence and Food Effect Bioavailability Study in Healthy Volunteers Comparing the Commercial Lumacaftor 200 mg / Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) to the Lumacaftor 200 mg Film-Coated Tablet Formulation, and the Lumacaftor 200 mg Film-Coated Tablet Formulation in the Fasted to Fed State

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Trial Profile

A Single-Dose, Bioequivalence and Food Effect Bioavailability Study in Healthy Volunteers Comparing the Commercial Lumacaftor 200 mg / Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) to the Lumacaftor 200 mg Film-Coated Tablet Formulation, and the Lumacaftor 200 mg Film-Coated Tablet Formulation in the Fasted to Fed State

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Dec 2023

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At a glance

  • Drugs Lumacaftor (Primary) ; Ivacaftor/lumacaftor
  • Indications Heart failure; Subarachnoid haemorrhage
  • Focus Pharmacokinetics
  • Sponsors Qanatpharma

Most Recent Events

  • 22 Dec 2023 Status changed from recruiting to completed.
  • 17 Oct 2023 New trial record
  • 16 Oct 2023 Planned End Date changed from 1 Nov 2023 to 1 Dec 2023.

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