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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Linezolid

• Registration Number: NCT01055769
• Lead Sponsor: Pfizer

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.

Detailed Description

To support Linezolid NDA in China.

Study Timeline

• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-26
• Study Start: 2010-03
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-03-04
• Results First Submitted QC: 2011-03-04
• Results First Posted: 2011-04-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-30
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Linezolid	Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG.
Group 2	Linezolid	Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	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).
Maximum Observed Plasma Concentration (Cmax)	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

Name	Time	Method
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	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)	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.
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	Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Shanghai, China