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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01055769
First received: January 22, 2010
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Linezolid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

  • 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 ] [ Designated as safety issue: No ]
    Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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-∞).

  • 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 ] [ Designated as safety issue: No ]
    The time of the first occurrence of peak concentration observed directly from data.

  • 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 ] [ Designated as safety issue: No ]
    Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.


Enrollment: 20
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

To support Linezolid NDA in China.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01055769     History of Changes
Other Study ID Numbers: A5951152
Study First Received: January 22, 2010
Results First Received: March 4, 2011
Last Updated: January 30, 2012
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014