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This study was carried out to compare the bioavailability of Hanmi clarithromycin (250 mg/tablet) with that of Klaricid^{(R)} The bioavailability was examined on 20 volunteers who received a single dose (500 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 12 hours. Plasma samples were analyzed for clarithromycin and roxithromycin(internal standard) by HPLC/Coulometric BCD. The pharmaco-kinetic parameters (AUC_{0-l2hr}, Cmax, Tmax, AUC_{inf}, Ka, Kel, t_{1/2}, Vd/F and Cl/F) were calculated from the plasma clarithromycin concentration-time data of each volunteer. The computer program ’’WinNonlin’’ was used for compartmental analysis. One compartment model with first-order input, from order output with lag time, weighting factor l/y^2 was chosen as the appropriate pharmacokinetic model. The major pharmacokinetic parameters (AUC_{0-l2hr},;AUC_{inf}, Cmax and Tmax) of Hanmi clarithromycin were 10.7pm0.5;{mu}g{cdot}hr{cdot}ml^{-1},;12.7pm0.7;{mu}g{cdot}hr{cdot}ml^{-1},;1.7pm0.1;{mu}g/ml;and;2.0pm0.2;hr, respectively, and those of Klaricid^{(R)};were;9.8pm0.5;{mu}g{cdot}hr{cdot}ml^{-1},;11.7pm0.6;{mu}g{cdot}hr{cdot}ml^{-1},;1.6pm0.1;{mu}g/ml;and;2.1pm0.1;hr, respectively. The differences in mean values of AUC_{0-l2hr},;AUC_{inf} and Cmax between two products were 9.88%,;8.94%;and;6.59%, respectively. The least significant differences at alpha=0.05 for AUC_{0-l2hr},;AUC_{inf} and Cmax were 16.08%,;17.81%;and;18.94%, respectively. Though the plasma clarithromycin concentrations of Hanmi clarithromycin were higher than those of Klaricid^{(R)} at all observed times, the bioavailability of Hanmi clarithromycin appeared to be bioequivalent with that of Klaricid^{(R)}. The Ka, Kel, t_{1/2}, Vd/F and Cl/F of the Hanmi clarithromycin were 2.69pm0.53;hr^{-1},;0.18pm0.01 hr^{-1},;3.9;hr,;248.8pm11.4;L;and;43.7pm2.6;L/hr, respectively, and those of Klaricid^{(R)} were 2.19pm0.51;hr^{-1},;0.18pm0.02;hr^{-1},;3.7;hr,;266.7pm22.4;L;and;45.3pm2.8L/hr, respectively. There were no statistically significant differences between two drugs in all pharmacokinetic parameters.
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