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Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects

NCT01055769 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-02-01

Study results available
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Summary

The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Linezolid

1. Linezolid OS 600 MG 2. Linezolid Tablet 600 MG

DRUG

Linezolid

1. Linezolid Tablet 600 MG 2. Linezolid OS 600 MG

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT01055769 on ClinicalTrials.gov