A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects
- *Corresponding Author:
- Yahdiana Harahap
Faculty of Mathematic and Natural Sciences
University of Indonesia
Depok, West Java Indonesia
E-mail: [email protected]
Received Date: April 18, 2012; Accepted Date: May 24, 2012; Published Date: May 26, 2012
Citation: Harahap Y, Prasaja B, Lusthom W, Hardiyanti, Ginting MB, et al. (2012) A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects. J Bioequiv Availab 4: 048-051. doi: 10.4172/jbb.10000111
Copyright: © 2012 Harahap Y, 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.
Aim: To compare the bioavailability of two Azithromycin tablet formulations 500 mg AzivolÃ¯Â¿Â½ tablets as test formulation and 500 mg ZithromaxÃ¯Â¿Â½ tablets as reference formulation. Methods: A single-dosed, open-label, randomized two-way crossover design under fasting period with two weeks wash-out period was evaluated in 24 subjects. For the analysis of pharmacokinetic properties, the blood samples were drawn taken up to 120 hours after dosing. Plasma concentration of Azithromycin was determined using liquid chromatography Ã¯Â¿Â½ tandem mass spectrometry method with TurboIon Spray mode. Pharmacokinetic parameters AUC0-t, AUC0-∞ and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax were evaluated non-parametrically. Results: The point estimates and 90% confidence intervals (CI) for AUC0-t, AUC0-∞ and Cmax for Azithromycin were 94.63% (86.27-103.81%), 95.35% (87.15-104.31%), 94.16% (80.31-110.41%) respectively. Conclusion: These results indicated that the two formulations of Azithromycin were bioequivalent and thus may be prescribed interchangeably.