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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Linezolid

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.