alexa Bioavailability Comparison of Two Zopiclone Formulations in Healthy Colombian 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

Bioavailability Comparison of Two Zopiclone Formulations in Healthy Colombian Volunteers

Adriana Ruiz1*, Fanny Cuesta2, Paula Castaño3, Omar Correa1, Karina Gómez1 and Maria Elena Jaramillo1

1Department of Pharmacy, Faculty of Pharmaceutical Chemistry, University of Antioquia, Medellín, Colombia

2Department of Pharmacology, Faculty of Medicine, University of Antioquia, Medellín, Colombia

3IPS Universitaria, Clínica León XIII, Medellín, Colombia

*Corresponding Author:
Adriana Ruiz
Professor, Department of Pharmacy
University of Antioquia
Medellín, Colombia
Tel: 5742195478
Fax: 5742195459
E-mail: [email protected]

Received Date: May 26, 2015 Accepted Date: July 22, 2015 Published Date: July 29, 2015

Citation: Ruiz A, Cuesta F, Castaño P, Correa O, Gómez K (2015) Bioavailability Comparison of Two Zopiclone Formulations in Healthy Colombian Volunteers. J Bioequiv Availab 7:233-238. doi:10.4172/jbb.1000246

Copyright: © 2015 Ruiz 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

Zopiclone is a hypnotic short-acting agent used in the treatment of primary insomnia. The aim of this study was to compare the Bioequivalence of two formulations of Zopiclone available in the Colombian market: Zopiclone 7.5 mg commercialized as Zopiclone MK® and Zopicloteg TG® (Test product) manufactured by Tecnoquímicas S.A (Cali, Col.) and Imovane® (Reference product) from Sanofi-Aventis Farmacéutica Ltda (Brasil). With this purpose, a single dose, randomized, crossover, with two periods, two sequences and a washout period of one week study was developed. Blood samples were drawn from 0 to 24 hours following the drug administration. Zopiclone plasma levels were determined by HPLC method, validated under the FDA parameters. The 90% confidence intervals for the ratios of the ln AUC0-∞ and ln Cmax means between the Test and Reference product were constructed. The 80/125 rule was used as bioequivalence criterion. The study was conducted in 26 healthy volunteers. The estimated pharmacokinetic parameters for Zopiclone, either for the Test product or Reference product were Cmax 72.815 ± 20.54 ng/mL, 74.315 ± 18.04 ng/mL; AUC0-t 467.297 ± 92.21 ng.h/mL, 460.996 ± 115.81 ng.h/mL, and AUC0-∞ 560.298 ± 118.58 ng.h/ mL, 543.549 ± 136.97 ng.h/mL, respectively. The 90% confidence intervals for the ratio between the averages of ln-transformed data of AUC0-∞ and Cmax were 97.38% - 110.59% and 89.97% - 104.84%, respectively.

Conclusion: In the present study of single dose, the Test product, Zopiclone 7.5 mg, meets the Bioequivalence criterion regarding the rate and extent of absorption.

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

Agri & Aquaculture Journals

Dr. Krish

[email protected]

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

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