alexa Bioequivalence of Omeprazole Delayed-Release Capsules in Healthy Filipino Subjects
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 Omeprazole Delayed-Release Capsules in Healthy Filipino Subjects

Qinying Zhao1*, Anna Plotka2, Grace Encelan-Brizuela3, Cynthia Ernst4, Jason Gobey1, Pamela Johnson1, Bernadette Dela Rosa3, Rita Grace Alvero5 and Bharat Damle1

1Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA

2Pfizer Inc., 500 Arcola Rd, Collegeville, PA 19426, USA

3Pfizer Inc., 23/F Ayala Life-FGU Center, 6811 Ayala Ave., Makati City

4ExecuPharm, 500 N Gulph Rd, King of Prussia, PA 19406, United States

5Bioavailability Unit, De La Salle Health Sciences Institute, Dasmarinas, Cavite, Philippines

*Corresponding Author:
Qinying Zhao
Pfizer Inc., 445 Eastern Point Road
Groton, CT 06340, USA
Tel: 860-441-1497
E-mail: [email protected]

Received Date: February 05, 2014; Accepted Date: August 22, 2014; Published Date: September 10, 2014

Citation: Zhao Q, Plotka A, Brizuela GE, Ernst C, Gobey J, et al. (2014) Bioequivalence of Omeprazole Delayed-release Capsules in Healthy Filipino Subjects. J Bioequiv Availab 6: 144-149. doi: 10.4172/jbb.10000195

Copyright: © 2014 Zhao Q, 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.



Study background: Omeprazole is indicated for the treatment of various acid-related gastrointestinal disorders. It is acid labile and therefore administered orally as enteric-coated granules in capsules. Methods: This randomized, open-label, single dose, two-way cross-over clinical pharmacology study in healthy adult Filipino subjects evaluated the bioequivalence of a new 40 mg delayed-release (enteric-film coated) capsule formulation of omeprazole (Pfizer Inc., US) relative to the reference marketed Losec® capsule (2x20 mg; AstraZeneca, Sweden; enteric-coated granules in capsule) under fasted conditions. Pharmacokinetic blood sampling was carried out at various time points for 12 h post-dose and plasma samples were analysed using a fully validated ultra performance liquid chromatography with tandem Mass Spectrometry technology. 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 omeprazole. Results: Twenty five subjects (12 females and 13 males; mean age 26 years; mean body mass index 24 kg/ m2) completed the study. When administered as one omeprazole 40 mg delayed-release capsule, the ratios of the adjusted geometric means of the primary endpoints, AUClast and Cmax, were contained within the established bioequivalence limits of 80 to 125% compared with two Losec® 20 mg capsules: 100.4% (90% confidence interval: 90.8–110.9%) and 90.4% (90% confidence interval: 81.2–100.6%), respectively. The two omeprazole formulations were well tolerated and no serious adverse event or other significant adverse event was noted. Conclusion: Based on the results of this study in healthy adult Filipino subjects, the new omeprazole 40 mg delayed-release capsule and the established marketed Losec® capsule (2x20 mg) are bioequivalent. Omeprazole 40 mg delayed-release capsule was safe and 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