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Effect of food on levothyroxine absorption following a single oral dose of 600 µg in healthy women: an randomised open-label pilot study

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Trial Profile

Effect of food on levothyroxine absorption following a single oral dose of 600 µg in healthy women: an randomised open-label pilot study

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2023

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At a glance

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

    • Most Recent Events

    • 04 Dec 2023 According to a IBSA Pharmaceutical Italy media release, based on results from two trials conducted by the Department of R&D and Scientific Affairs - IBSA Institut Biochimique SA, the U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL, the label updated removes PPIs as a drug that may decrease the absorption and reduce the efficacy of Tirosint-SOL. Similarly, updated label indicates that it can be administered 15 minutes before eating breakfast.
    • 01 Aug 2022 Results assessing the bioavailability of LT4 solution (Tirosint R-SOL) preparation taken 15 minutes before a high-fat high-calorie meal in comparison with the minimally recommended 30-minute interval, published in the Thyroid.
    • 26 May 2021 According to an IBSA media release, based on the results from the study IBSA Institut Biochimique SA, the sponsor of the study, anticipates seeking FDA approval for a change in the approved labelling for Tirosint-SOL to include dosing either 15 minutes or 30 minutes in advance of eating breakfast.
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