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

NCT ID: NCT01055769

Last Updated: 2012-02-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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To support Linezolid NDA in China.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Group 1

Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG.

Group Type OTHER

Linezolid

Intervention Type DRUG

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

Group 2

Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.

Group Type OTHER

Linezolid

Intervention Type DRUG

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

Interventions

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Linezolid

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

Intervention Type DRUG

Linezolid

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

Intervention Type DRUG

Other Intervention Names

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Zyvox Zyvox

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers.
* 18-40 years old, male.
* BMI 19-24kg/m2.

Exclusion Criteria

* Alcohol, drug, smoke user.
* Sensitive to oxazolidinones antibiotics class drug or heparin.
* Severe medical or psychiatric condition or laboratory abnormality.
* Blood donation.
* 12-ECG abnormal.
* Treatment with study drug; clinically significant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Shanghai, , China

Site Status

Countries

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China

Related Links

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Other Identifiers

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A5951152

Identifier Type: -

Identifier Source: org_study_id

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