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PK and Safety of Saroglitazar Magnesium in Hepatic Impairment, Cholestatic Liver Disease, and NASH
NCT04469920Phase 1Completed
- Sponsor
- Zydus Therapeutics
- Start
- Jul 2020
- Primary completion
- Mar 2022
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, open-label trial of saroglitazar in Nonalcoholic steatohepatitis (NASH) and cholestatic liver disease (CLD) (7 arms), sponsored by Zydus Therapeutics. Primary endpoints: Area Under the Curve from time zero to infinity at Day 7, Area Under the Curve from time zero to last quantifiable concentration at Day 7 and 5 more. Started Jul 2020; status: completed.
02
Drugs
saroglitazar
03
Conditions
Nonalcoholic steatohepatitis (NASH)cholestatic liver disease (CLD)
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