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NCT04112446 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects

A Phase 1 study, sponsored by Zydus Therapeutics.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target

NCT04112446 is a Phase 1 study that has completed, run by Zydus Therapeutics. The registered enrollment target is 8 participants.

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The verdict

NCT04112446, a Phase 1 study, has completed, sponsored by Zydus Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.

Interventions

  • DRUG Saroglitazar magnesium

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2019-09-20
Est. Completion 2019-10-29
Phase Phase 1

Sponsor

Zydus Therapeutics

15 total trials

What the Registry Record Tells You About NCT04112446

The ClinicalTrials.gov registry entry for NCT04112446 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zydus Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Saroglitazar magnesium is the first listed.

NCT04112446 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04112446 about?

NCT04112446 is a clinical study titled "Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects". This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.

What is the current status of trial NCT04112446?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-09-20. Estimated completion is 2019-10-29.

What interventions are being tested in trial NCT04112446?

The interventions under investigation include: Saroglitazar magnesium (DRUG).

Who is sponsoring clinical trial NCT04112446?

This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.