Relative bioavailability and bioequivalence of azithromycin tablets in healthy volunteers / 南方医科大学学报

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the bioavailability and bioequivalence of azithromycin tablets in healthy volunteers.</p><p><b>METHODS</b>A single dose (500 mg) of azithromycin tablet (from 3 pharmaceutical companies) was given to 18 healthy volunteers according to a randomized cross-over design. The plasma concentrations of azithromycin were determined by liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS).</p><p><b>RESULTS AND CONCLUSION</b>The T(max) of azithromycin products of the 3 pharmaceutical companies were 2.3-/+1.1, 3.0-/+1.1 and 2.9-/+0.8 h, C(max) were 319.2-/+176.7, 303.10-/+144.60 and 313.70-/+165.00 ng/ml, AUC(0-144) were 5073.60-/+2933.00, 4296.80-/+1896.20 and 4797.80-/+3234.00 ng.h/ml, AUC(0-max) were 5461.60-/+3236.00, 4804.40-/+2162.90 and 5163.20-/+3497.50 ng.h/ml, respectively. Statistical analysis of the above main pharmacokinetic parameters of azithromycin tablets suggests the bioequivalence of the three formulations.</p>