Bioequivalence of clarithromycin tablet formulations assessed in Korean males.
OBJECTIVE
Determination of the bioequivalence of 2 clarithromycin tablet formulations manufactured in Korea.


METHODS
Twenty-four healthy male Korean volunteers received each of the 2 clarithromycin formulations at a dose of 250 mg in a 2 x 2 crossover study. There was a one-week washout period between doses. Plasma concentrations of clarithromycin were monitored by high-performance liquid chromatography over a period of 12 hours after administration. AUCinf (the area under the plasma concentration-time curve from time zero to time infinity) was calculated using the linear-log trapezoidal method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCinf and Cmax and untransformed Tmax.


RESULTS
The point estimates and 90% confidence intervals for AUCinf (parametric) and Cmax (parametric) were 0.971 (0.886 approximately 1.063) and 0.982 (0.868 approximately 1.107), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines. The corresponding value of Tmax was 0.000 (-0.250 approximately 0.250).


CONCLUSIONS
These results indicate that the 2 medications of clarithromycin are bioequivalent and, thus, may be prescribed interchangeably.
Kim
Y G
YG
College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Yongin, Korea.
Kim
H J
HJ
Kwon
J W
JW
Kim
W B
WB
Lee
M G
MG
D000328:Adult; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D017291:Clarithromycin / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency
D000900:Anti-Bacterial Agents; D013607:Tablets; D017291:Clarithromycin