alexa Pharmacokinetics and Bioequivalence Comparison of 600 m
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

Like us on:
OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Research Article

Pharmacokinetics and Bioequivalence Comparison of 600 mg Single-Dose Linezolid Oral Suspension and Tablet Formulation in Healthy Chinese Subjects

Jing Zhang1, Yingyuan Zhang1, Ronnie Wang2, Christine Alvey2, Qiang Wang2, Bharat Damle2 and Huifen Faye Wang2*

1Hua Shan Hospital Affiliated to Fudan University, Shanghai, China

2Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA

*Corresponding Author:
Huifen Faye Wang
Pfizer Inc., 445 Eastern Point Road
Groton, CT 06340, USA
Tel: 0018604415063
Fax: 0018607159499
E-mail: [email protected]

Received Date: August 06, 2014; Accepted Date: September 23, 2014; Published Date: September 26, 2014

Citation: Zhang J, Zhang Y, Wang R, Alvey C, Wang Q, et al. (2014) Pharmacokinetics and Bioequivalence Comparison of 600 mg Single-Dose Linezolid Oral Suspension and Tablet Formulation in Healthy Chinese Subjects. J Bioequiv Availab 6: 153-157. doi: 10.4172/jbb.10000197

Copyright: © 2014 Zhang J, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Study background:Linezolid is indicated for the treatment of infections caused by aerobic Gram-positive bacteria. An oral suspension formulation poses an alternative to solid oral formulations in patients with swallowing difficulties, especially pediatric and geriatric patients, or patients with feeding tubes. Methods: This randomized, open-label, two-way cross-over, clinical pharmacology study in healthy Chinese male subjects evaluated the bioequivalence of single-dose 600 mg linezolid oral suspension to single-dose 600 mg linezolid film-coated tablet under fasted conditions. Pharmacokinetic blood sampling was carried out at various time points within 48 h post-dosing and plasma samples were analyzed using a validated high-performance liquid chromatography tandem mass spectrometric method. The primary endpoints were area under plasma concentration– time curve (AUC) from time zero to the time of the last quantifiable concentration (AUClast) and maximum plasma concentration (Cmax)for linezolid. Results: All 20 enrolled male subjects completed the study (mean age 25 years, mean body mass index 22 kg/ m2). The 90% confidence intervals (CIs) for the ratios of the adjusted geometric means of the primary endpoints, AUClast(97.81% [90% CI, 93.11-102.75%])and Cmax (113.67% [90% CI, 105.26-122.75%]), for the oral suspension formulation compared with the oral tablet were fullywithin the established bioequivalence limits of 80-125%. The two linezolid formulations were well tolerated and no serious adverse event or other significant adverse event was noted. Conclusions: Based on the results of this study, linezolid 600 mg oral suspension and linezolid 600 mg tablets are anticipated to be therapeutically equivalent and could be switched in subjects without any need for dose modification. Both formulations were safe and well tolerated.

Keywords

Share This Page

Additional Info

Loading
Loading Please wait..
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords