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A bioequivalence study of two azithromycin tablet formulations in Indonesian healthy subjects

ABSTRACT Abstract
Aim: To compare the bioavailability of two Azithromycin tablet formulations 500 mg Azivol® tablets as test
formulation and 500 mg Zithromax® 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 – 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.

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May 29, 2014