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Completed

NCT Number: NCT01055769

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Shanghai, 200040, China

About this study

To support Linezolid NDA in China.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Linezolid

Drug
  • Linezolid OS 600 MG
  • Linezolid Tablet 600 MG

Other names: Zyvox

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 26, 2010
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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