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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

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: 13 Jun 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

  • 29 May 2025 Planned primary completion date changed from 31 Aug 2025 to 31 May 2025.
  • 19 Feb 2025 New trial record

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