deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT04045769

A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers

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

Sponsor: Zydus Therapeutics Inc.

Conditions Healthy
Updated 6 times since 2019 Last updated: Apr 20, 2020 Started: Aug 19, 2019 Primary completion: Nov 27, 2019 Completion: Dec 2, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04045769, this PHASE1 trial focuses on Healthy and remains completed. Sponsored by Zydus Therapeutics Inc., it has been updated 6 times since 2019, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Sep 2019 – ~May 2020 · 8 months · monthly snapshotRecruiting~May 2020 – ~Jan 2021 · 8 months · monthly snapshotCompleted~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Oct 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE1

  5. May 2020 — Jan 2021 [monthly]

    Completed PHASE1

    Status: RecruitingCompleted

Show 1 earlier version
  1. Sep 2019 — May 2020 [monthly]

    Recruiting PHASE1

    First recorded

Aug 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Zydus Therapeutics Inc.
Data source: Zydus Therapeutics Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations