Bioequivalence Of Clarithromycin Tablet Formulations Assessed In Korean Males

Aim: Determination of the bioequivalence of 2 clarithromycin tablet formulations manufactured in Korea. Patients and 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 at, ter administration. AUC(inf) (the area under the plasma concentration-time curve from time zero to time infinity) was calculated using the linear-log trapezoidal method. C-max (maximum plasma drug concentration) and T-max (time to reach C-max) were compiled from the plasma concentration-time data. Analysis of I variance was carried out using logarithmically transformed AUC(inf) and C-max and untransformed T-max. Results: The point estimates and 90% confidence intervals for AUC(inf) (parametric) and C-max (parametric) were 0.971 (0.886 similar to 1.063) and 0.982 (0.868 similar to 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 Tma, was 0.000 (-0.250 similar to 0.250). Conclusion: These results indicate that the 2 medications of clarithromycin are bioequivalent and, thus, may be prescribed interchangeably.