alexa Pharmacokinetics and Bioequivalence Evaluation of Two Voriconazole tablets: an Open-Label, Single-Dose, Randomized, Two-Way Crossover Study in Healthy Chinese Male Volunteers
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 Evaluation of Two Voriconazole tablets: an Open-Label, Single-Dose, Randomized, Two-Way Crossover Study in Healthy Chinese Male Volunteers

Xuewen Qiu, Rongfeng Xiang, Qing Dai, Bo Yang, Lirong Xiong, Yangjing Ou, Min Tang, Yongchuan Chen*

Department of Pharmacy, Southwest hospital, Chongqing, China, 40003

*Corresponding Author:
Yongchuan Chen
Department of Pharmacy, Southwest hospital
29TH, Gaotangyan Street, Shapingba District
Chongqing, China, 40003
Tel/Fax: 0086-023-68754462
E-mail: [email protected]

Received Date: April 19, 2012; Accepted Date: May 19, 2012; Published Date: May 21, 2012

Citation: Qiu X, Xiang R, Dai Q, Yang B, Xiong L, et al. (2012) Pharmacokinetics and Bioequivalence Evaluation of Two Voriconazole tablets: an Open-Label, Single-Dose, Randomized, Two-Way Crossover Study in Healthy Chinese Male Volunteers. J Bioequiv Availab 4: 044-047. doi: 10.4172/jbb.10000110

Copyright: © 2012 Qiu X, 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.



The aim of this study was to assess and compare the pharmacokinetic properties, bioavailability, and bioequivalence of a newly developed tablet of voriconazole with those of an established branded formulation in healthy Chinese adult male volunteers. An open-label, single-dose, randomized, 2-way crossover study was conducted in fasted healthy Chinese male volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive one tablet (200 mg) of the test or reference formulations, followed by a 1-week washout period and administration of the alternate formulations. Plasma samples were collected over 36 hours and analyzed by HPLC. The Voriconazole plasma concentration�time curves were used to obtain pharmacokinetic parameters including AUC0�t, AUC0�∞, Cmax and Tmax. The criteria for bioequivalence were 90% CIs of 80% to 125% for AUC and 70% to 143% for Cmax, and no significant differences for Tmax with a non-parameter test, according to guidelines of the SFDA of China. Tolerability was based on the recording of adverse events (AEs). A total of 19 volunteers were included in the study. The mean (SD) Cmax, Tmax, AUC0�t, and AUC0�∞ values after administration of the test and reference formulation, respectively, were as follows: 925.73(356.11) versus 1040.25(448.93) ng/mL, 1.57(0.98) versus 1.38(0.96) hours, 5304.97(3072.25) versus 5141.63(2976.92) ng/mL/h, and 5783.21(3266.86) versus 5520.69(3148.42) ng/mL/h. The relative bioavailability of the test formulation was 103.2% by mean AUC0�t and 104.8% by mean AUC0−∞. The 90% CIs for the ratios of Cmax, AUC0�t, and AUC0−∞ were 77.3% to 122.7%, 85.7% to 114.3%, and 83.6% to 116.4%, respectively, meeting the predetermined criteria for bioequivalence. No drug-related AEs were observed. In this study the test and reference formulations had similar PK parameters and similar plasma concentration-time profiles and the test formulations met the regulatory criteria for bioequivalence to the established reference formulations based on the rate and extent of absorption. Both formulations were well tolerated.

Share This Page

Additional Info

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

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

[email protected]

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals


[email protected]

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

[email protected]

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001 Extn: 9042

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