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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime

NCT02532140 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-05-03

No results posted yet for this study

Summary

• To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

Conditions

  • Healthy

Interventions

DRUG

WCK 5107 250 mg to 2000 mg

DRUG

Cefepime 2000 mg

DRUG

WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

DRUG

Placebo

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Wockhardt

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02532140 on ClinicalTrials.gov