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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Linezolid (Drug); Linezolid (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Terminal Half-Life (t1/2)

Detailed description: To support Linezolid NDA in China.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Male.

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.

Locations and Contacts

Pfizer Investigational Site, Shanghai 200040, China
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2010
Last updated: January 30, 2012

Page last updated: August 23, 2015

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