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NCT04045769
A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
Phase 1 trial testing Saroglitazar magnesium 4mg in Healthy in 52 participants. Completed in 2 December 2019.
27 November 2019
Quick facts
| Lead sponsor | Zydus Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 52 |
| Start date | 19 August 2019 |
| Primary completion | 27 November 2019 |
| Estimated completion | 2 December 2019 |
| Sites | 1 location across India |
Drugs / interventions tested
- Saroglitazar magnesium 4mg — full drug profile →
- Placebos — full drug profile →
- Moxifloxacin 400mg — full drug profile →
- Saroglitazar magnesium 20 mg — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Zydus Therapeutics Inc. — full company profile →
Who can join
Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04045769
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Zydus Therapeutics Inc. trials
Trials by the same sponsor.
- NCT06825559 — Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease · Phase 1 · recruiting
- NCT06427395 — Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis · Phase 3 · recruiting
- NCT05211284 — Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US · Phase 2 · terminated
- NCT05133336 — Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis · Phase 2, PHASE3 · completed
- NCT05045482 — Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04045769 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zydus Therapeutics Inc.
- Last refreshed: 21 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04045769.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing