alexa Bioequivalence of Omeprazole Delayed-Release Capsules i
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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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.

 

Abstract

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.

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