[Relative bioavailability and bioequivalence of azithromycin tablets in healthy volunteers].
OBJECTIVE
To evaluate the bioavailability and bioequivalence of azithromycin tablets in healthy volunteers.


METHODS
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).


CONCLUSIONS
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.
Yang
Ling
L
Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
Zheng
Heng
H
Tu
Ning
N
D017963:Azithromycin / Q000097:blood / Q000493:pharmacokinetics*; D001682:Biological Availability; D002138:Calibration; D006262:Health; D006801:Humans; D008297:Male; D015203:Reproducibility of Results; D013607:Tablets; D013810:Therapeutic Equivalency
D013607:Tablets; D017963:Azithromycin