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

NCT04045769 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-04-21

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Saroglitazar magnesium 4mg

1 tablet of 4 mg Saroglitazar magnesium; 4 tablets of placebo to be administered orally

DRUG

Placebos

5 tablets of placebo to be administered orally

DRUG

Moxifloxacin 400mg

1 tablet of 400 mg Moxifloxacin to be administered orally

DRUG

Saroglitazar magnesium 20 mg

5 tablets of 4 mg Saroglitazar magnesium to be administered orally

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Deven V Parmar, MD,FCP · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2019-11-27
Completion
2019-12-02
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045769 on ClinicalTrials.gov