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PK and Safety of Saroglitazar Magnesium in Renal Impairment
NCT04446507Phase 1Completed
- Sponsor
- Zydus Therapeutics
- Start
- Jul 2020
- Primary completion
- May 2024
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, open-label trial of saroglitazar magnesium in diabetic dyslipidemia, hypertriglyceridemia, type 2 diabetes mellitus (T2DM) and 2 more (2 arms), sponsored by Zydus Therapeutics. Primary endpoints: Area Under the Concentration-time Curve From Time Zero to Infinity, Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration and 5 more. Started Jul 2020; status: completed.
02
Drugs
saroglitazar magnesium
03
Conditions
diabetic dyslipidemiahypertriglyceridemiatype 2 diabetes mellitus (T2DM)Nonalcoholic steatohepatitis (NASH)primary biliary cholangitis (PBC)
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