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Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

NCT02253342 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-10-29

No results posted yet for this study

Summary

This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.

Conditions

  • Intrapulmonary Pharmacokinetics of WCK 2349

Interventions

DRUG

WCK-2349

Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1

Sponsors & Collaborators

  • Clinartis

    collaborator INDUSTRY

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Mark H Gotfried, MD · Pulmonary Associates, PA

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2015-08-31

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 NCT02253342 on ClinicalTrials.gov