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A Bioequivalence Study of Liquid Formulation of Levothyroxine (ET-103)

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Trial Profile

A Bioequivalence Study of Liquid Formulation of Levothyroxine (ET-103)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Mar 2020

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At a glance

  • Drugs Levothyroxine sodium (Primary)
  • Indications Hypothyroidism
  • Focus Pharmacokinetics
  • Sponsors Eton Pharmaceuticals

Most Recent Events

  • 05 Mar 2020 According to an Eton Pharmaceuticals media release, the company Eton is in discussions with the FDA regarding bioequivalence data results to ensure compliance with FDA requirements prior to submission of the NDA and once company receives agreement from the FDA it expects to submit NDA in the first half of 2020.
  • 13 Jun 2019 According to an Eton Pharmaceuticals media release, the company expects study results in September and, if successful, plans to submit the NDA in the fourth quarter of 2019.
  • 01 Apr 2019 New trial record

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