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Clinical study of levothyroxine sodium in conjunction with omeprazole versus Tirosint-SOL therapy alone in helathy volunteers

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Trial Profile

Clinical study of levothyroxine sodium in conjunction with omeprazole versus Tirosint-SOL therapy alone in helathy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Dec 2023

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At a glance

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.
  • 05 Jan 2022 New trial record

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