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Evaluation of Pharmacokinetics and Safety of Saroglitazar Magnesium in Participants With Normal Hepatic Function and With Hepatic Impairment, Cholestatic Liver Disease, NASH With Advanced Fibrosis

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Trial Profile

Evaluation of Pharmacokinetics and Safety of Saroglitazar Magnesium in Participants With Normal Hepatic Function and With Hepatic Impairment, Cholestatic Liver Disease, NASH With Advanced Fibrosis

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Oct 2023

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At a glance

  • Drugs Saroglitazar (Primary)
  • Indications Hepatic fibrosis; Liver disorders; Non-alcoholic steatohepatitis; Primary biliary cirrhosis; Primary sclerosing cholangitis
  • Focus Pharmacokinetics
  • Sponsors Zydus Discovery DMCC

    • Most Recent Events

    • 06 Aug 2023 Planned End Date changed from 1 Oct 2023 to 1 Oct 2024.
    • 06 Aug 2023 Planned primary completion date changed from 1 Jun 2023 to 1 Mar 2024.
    • 03 Feb 2023 Planned End Date changed from 1 Oct 2022 to 1 Oct 2023.

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