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Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

NCT02244827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-10-29

No results posted yet for this study

Summary

This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment and healthy volunteers.

Conditions

  • Hepatic Impairment

Interventions

DRUG

WCK 2349

levonadifloxacin (active drug) and the sulfate metabolite

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Richard A Preston, M.D. · Division of Clinical Pharmacology,University of Miami

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2015-06-30

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 NCT02244827 on ClinicalTrials.gov