Completed PHASE1 INTERVENTIONAL 1-arm NCT04112446

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

A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Saroglitazar Following a Single Oral Dose of [14C]-Saroglitazar Magnesium in Healthy Male Subjects

Sponsor: Zydus Therapeutics Inc.

Conditions Healthy

Interventions Saroglitazar magnesium

Updated 6 times since 2019 Last updated: Nov 11, 2019 Started: Sep 20, 2019 Primary completion: Oct 29, 2019 Completion: Oct 29, 2019

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Healthy, this trial is completed. The trial is conducted by Zydus Therapeutics Inc. and has accumulated 6 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Oct 2021 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Oct 2021 [monthly]

Completed PHASE1
Dec 2019 — Jan 2021 [monthly]

Completed PHASE1

Status: Recruiting → Completed

▶ Show 1 earlier version

Nov 2019 — Dec 2019 [monthly]

Recruiting PHASE1

First recorded

Sep 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

• Madison, United States