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A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment with Cirrhosis Due to Cholestatic Liver Disease

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Trial Profile

A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment with Cirrhosis Due to Cholestatic Liver Disease

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Jul 2025

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At a glance

  • Drugs Saroglitazar (Primary)
  • Indications Biliary cirrhosis; Liver disorders
  • Focus Pharmacokinetics
  • Sponsors Zydus Pharmaceuticals (USA)

Most Recent Events

  • 30 Jun 2025 Planned initiation date changed from 31 May 2025 to 30 Aug 2025.
  • 22 May 2025 Planned initiation date changed from 31 Mar 2025 to 31 May 2025.
  • 19 Feb 2025 New trial record

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