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ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
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Research Article

Pharmacokinetic Comparison and Bioequivalence Study of Two Rosuvastatin 20 mg Formulations in Healthy Volunteers

Wen Yao Mak1*, Siew Siew Tan2, Jia Woei Wong2, Siaw Kuen Chin2, Ai Boey Lim2, Ean Peng Soon2, Irene Looi1 and Kah Hay Yuen2

1Clinical Research Centre, Hospital Seberang Jaya, Jalan Tun Hussein Onn, 13700 Seberang Jaya, Pulau Pinang, Malaysia

2Attest Research Sdn Bhd, Room 024, Kompleks EUREKA, Universiti Sains Malaysia, 11800 USM, Pulau Pinang, Malaysia

*Corresponding Author:
Wen Yao Mak
Clinical Research Centre, Hospital Seberang Jaya
Jalan Tun Hussein Onn, 13700 Perai, Pulau Pinang, Malaysia
Tel: 04-3827333 Ext 511
Fax: 04-3902192
E-mail: [email protected]

Received Date: January 04, 2016 Accepted Date: January 27, 2016 Published Date: February 03, 2016

Citation: Mak WY, Tan SS, Wong JW, Chin SK, Lim AB, et al. (2016) Pharmacokinetic Comparison and Bioequivalence Study of Two Rosuvastatin 20 mg Formulations in Healthy Volunteers. J Bioequiv Availab 8: 095-098. doi: 10.4172/jbb.1000275

Copyright: © 2016 Mak WY, 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

The present study investigated the pharmacokinetics and bioequivalence between two oral rosuvastatin formulations. The study was designed as a two-way crossover, two-period, open-label, randomised, single-dose investigation. Washout period was determined as 14 days due to the long elimination half-life of rosuvastatin. Bioanalysis of plasma samples was performed via liquid chromatography tandem mass spectrometry. The pharmacokinetic parameters were analysed with the non-compartmental model. The study showed AUC0-t, AUC0-∞, and Cmax were within the limit of 80.00%-125.00%, and concluded the two products were bioequivalent and interchangeable.

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