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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055769

A5951152

Details and patient eligibility

About

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.

Full description

To support Linezolid NDA in China.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

Group 1

Other group

Description:

Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG.

Treatment:

Drug: Linezolid

Drug: Linezolid

Group 2

Other group

Description:

Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.

Treatment:

Drug: Linezolid

Drug: Linezolid