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

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ClinicalTrials.gov Identifier: NCT01055769
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : April 5, 2011
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Linezolid Phase 1

Detailed Description:
To support Linezolid NDA in China.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open Label, Single Dose, 2-Way, Randomized Cross-Over Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
Study Start Date : March 2010
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Group 1
Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG.
Drug: Linezolid
  1. Linezolid OS 600 MG
  2. Linezolid Tablet 600 MG
Other Name: Zyvox
Group 2
Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.
Drug: Linezolid
  1. Linezolid Tablet 600 MG
  2. Linezolid OS 600 MG
Other Name: Zyvox


Outcome Measures

Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose ]
    Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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 within the dosing interval was directly obtained from the concentration-time data.


Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose ]
    AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose ]
    The time of the first occurrence of peak concentration observed directly from data.

  3. Terminal Half-Life (t1/2) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose ]
    Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055769


Locations
China
Pfizer Investigational Site
Shanghai, China, 200040
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01055769     History of Changes
Other Study ID Numbers: A5951152
First Posted: January 26, 2010    Key Record Dates
Results First Posted: April 5, 2011
Last Update Posted: February 1, 2012
Last Verified: January 2012

Keywords provided by Pfizer:
Bio-equivalence
Linezolid OS
Linezolid tablet

Additional relevant MeSH terms:
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action