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

Study Overview
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Brief Summary
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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
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To support Linezolid NDA in China.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Linezolid
* Drug: Linezolid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG. | Drug: Linezolid<br>* Linezolid OS 600 MG Linezolid Tablet 600 MG<br>* Other names: Zyvox;|
| Other: Group 2<br>Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG. | Drug: Linezolid<br>* Linezolid Tablet 600 MG Linezolid OS 600 MG<br>* Other names: Zyvox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] | 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-∞). | 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) | The time of the first occurrence of peak concentration observed directly from data. | 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) | Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. | 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bio-equivalence, Linezolid OS, Linezolid tablet