NCT01055769

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 5, 2011

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

January 22, 2010

Results QC Date

March 4, 2011

Last Update Submit

January 30, 2012

Conditions

Healthy Volunteers

Keywords

Bio-equivalenceLinezolid OSLinezolid tablet

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

    0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

  • Maximum Observed Plasma Concentration (Cmax)

    Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.

    0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Secondary Outcomes (3)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

    0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

  • Terminal Half-Life (t1/2)

    0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Study Arms (2)

Group 1

OTHER

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

Drug: Linezolid

Group 2

OTHER

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

Drug: Linezolid

Interventions

LinezolidDRUG

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

Also known as: Zyvox
Group 1

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers.
  • years old, male.
  • BMI 19-24kg/m2.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Shanghai, 200040, China

Location

Related Links

MeSH Terms

Interventions

Linezolid

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 26, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 1, 2012

Results First Posted

April 5, 2011

Record last verified: 2012-01

Locations

CN(1)