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Saroglitazar QTc Study in Healthy Volunteers
NCT04045769Phase 1Completed
- Sponsor
- Zydus Therapeutics
- Start
- Aug 2019
- Primary completion
- Nov 2019
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of saroglitazar magnesium in diabetic dyslipidemia and Nonalcoholic steatohepatitis (NASH) (4 arms), sponsored by Zydus Therapeutics. Primary endpoints: QTcF change-from-baseline and Saroglitazar and its metabolite saroglitazar sulfoxide plasma concentrations and placebo-corrected change-from-baseline QTcF. Started Aug 2019; status: completed.
02
Drugs
saroglitazar magnesium
03
Conditions
diabetic dyslipidemiaNonalcoholic steatohepatitis (NASH)
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