Journal of Pharmaceutical Care & Health Systems
Open Access

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

European Pharma Congress

August 25-27, 2015 Valencia, Spain

Yahdiana Harahap1, Budi Prasaja2, Windy Lusthom2, Hardiyanti2, Mena Bertony Ginting2 and Lipin2

1Universitas Indonesia, Indonesia 2PT. Clinisindo Laboratories, Indonesia

Scientific Tracks Abstracts: J Pharma Care Health Sys

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 chromatographyâ�?�?tandem mass spectrometry method with TurboIon Spray mode. Pharmacokinetic parameters AUC0-t, AUC0-â�?�? 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-â�?�?, and Cmax for azithromycin were 94.63% (86.27- 103.81%), 95.35% (87.15-104.31%), and 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.

Biography :

Email: yahdiana03@yahoo.com