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Bioequivalence study of TIGLUTIK ® (riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) with a Percutaneous Endoscopic Gastronomy (PEG) Feeding Tube

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Trial Profile

Bioequivalence study of TIGLUTIK ® (riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) with a Percutaneous Endoscopic Gastronomy (PEG) Feeding Tube

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Dec 2019

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At a glance

  • Drugs Riluzole (Primary) ; Riluzole
  • Indications Amyotrophic lateral sclerosis
  • Focus Pharmacokinetics
  • Sponsors ITF Pharma

Most Recent Events

  • 20 Dec 2019 New trial record
  • 13 Dec 2019 Results presented in an ITF Pharma Media Release.
  • 13 Dec 2019 According to an ITF Pharma media release, based on this study, the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for TIGLUTIK(riluzole) oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of amyotrophic lateral sclerosis (ALS).

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