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Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349

NCT04874324 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-12-01

No results posted yet for this study

Summary

The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.

Conditions

  • Pharmacokinetics

Interventions

DRUG

WCK 2349 Oral

1 dose given orally twice daily at 12 hourly interval for five days.

OTHER

Placebo Oral

Subjects will receive matching placebo

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Ashima Bhatia, MD · Wockhardt Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2011-03-17
Primary Completion
2011-05-04
Completion
2011-06-25
FDA Drug
Yes

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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 NCT04874324 on ClinicalTrials.gov