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[14C]-Saroglitazar AME Study in Healthy Males
NCT04112446Phase 1Completed
- Sponsor
- Zydus Therapeutics
- Start
- Sep 2019
- Primary completion
- Oct 2019
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, open-label, single-arm trial of saroglitazar magnesium in diabetic dyslipidemia, hypertriglyceridemia, Nonalcoholic steatohepatitis (NASH) and 1 more, sponsored by Zydus Therapeutics. Primary endpoints: AUC from time zero to infinity at Day 12, AUC from time zero to the last quantifiable concentration at Day 12 and 10 more. Started Sep 2019; status: completed.
02
Drugs
saroglitazar magnesium
03
Conditions
diabetic dyslipidemiahypertriglyceridemiaNonalcoholic steatohepatitis (NASH)primary biliary cholangitis (PBC)
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