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