alexa Bioequivalence of the Emtricitabine/Rilpivirine/Tenofov
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

Bioequivalence of the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Single Tablet Regimen

A Mathias*, M Menning, L Wiser, X Wei, A Dave, S Chuck and BP Kearney

Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA

*Corresponding Author:
Anita Mathias
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404, USA
Tel: (650)522-3000
Fax: (650)522-5801
E-mail: [email protected]

Received Date: September 10, 2012; Accepted Date: September 20, 2012; Published Date: September 25, 2012

Citation: Mathias A, Menning M, Wiser L, Wei X, Dave A, et al. (2012) Bioequivalence of the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Single Tablet Regimen. J Bioequiv Availab 4: 100-105. doi: 10.4172/jbb.1000121

Copyright: © 2012 Mathias A, 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

Emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) is a next-generation, once-daily
complete antiretroviral single-tablet regimen for the treatment of HIV-1 infection in adults. This study evaluated the pharmacokinetics and bioequivalence of 2 distinct investigational coformulations of the FTC/RPV/TDF single-tablet regimen (containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir disoproxil fumarate 300 mg) compared with the concurrent administration of a 200-mg strength capsule of FTC, a 25-mg strength tablet of RPV, and a 300-mg strength tablet of tenofovir disoproxil fumarate in healthy subjects. Thirty-six subjects were randomized in a single-dose, open-label, 3-way crossover study design; 34 subjects completed all study treatments. Serial blood samples were obtained over 192 hours following oral administration of each treatment and pharmacokinetic parameters calculated. Formulation bioequivalence was assessed by 90% confidence intervals (CI) for the ratio of geometric least square means (GMR) for Cmax, AUClast and AUCinf for each drug of the FTC/RPV/TDF single-tablet regimen versus the individual components. Emtricitabine, rilpivirine, and tenofovir disoproxil fumarate administered under fed conditions (standardized meal of ~400 kcal) as individual drugs given concurrently or as a fixed‑dose combination tablet were generally well tolerated. Of the 2 single-tablet formulations that were tested, a single coformulation (Test Formulation 1) demonstrated bioequivalence to the reference formulation, with 90% confidence intervals for the ratio of the geometric least-squares means contained within the bounds of 80% to 125% for the AUCinf, AUC0−last, and Cmax values of emtricitabine, rilpivirine, and tenofovir, and was carried forward as the commercial formulation. This tablet is a next-generation, once-daily single-tablet antiretroviral regimen for the treatment of HIV-1
infection and offers an attractive treatment option to efavirenz-containing regimens.

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