Overview

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.