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Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers

NCT03554304 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-13

No results posted yet for this study

Summary

A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers

Conditions

  • QT/QTc Interval in Healthy Volunteers

Interventions

DRUG

WCK 5222

FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)

DRUG

IV placebo matched to WCK 5222 / Moxifloxacin IV solution

Placebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet

DRUG

Moxifloxacin 400-mg

Moxifloxacin 400-mg positive control (overencapsulated tablet)

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-02-09
Primary Completion
2017-06-05
Completion
2017-10-06
FDA Drug
Yes

Countries

  • United States

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 NCT03554304 on ClinicalTrials.gov