Pharmacokinetics and bioequivalent of azithromycin dispersible tablets in healthy volunteers
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Abstract
Objective: To evaluate the bioequivalence of two domestic preparations of azithromycin in healthy volunteers.Methods: A single oral dose of 500 mg test or reference formulations were given to 20 male healthy volunteers in a randomized cross-over design.The serum concentration of azithromycin was determined by liquid chromatography-tandem mass spectrometry method.Pharmacokinetic parameters and relative bioavailability were calculated by DAS program.Results: Pharmacokinetic parameters of test and reference were not statistically different(P>0.05).The relative bioavailability of test was(119.6±52.9)%.Conclusions: The test and reference formulations were bioequivalent.
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