earticle

영어

This study was carried out to compare the bioavailability of Hanmi clarithromycin (250 mg/tablet) with that of 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 (, Cmax, Tmax, , Ka, Kel, , 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 was chosen as the appropriate pharmacokinetic model. The major pharmacokinetic parameters (, Cmax and Tmax) of Hanmi clarithromycin were , respectively, and those of , respectively. The differences in mean values of and Cmax between two products were , respectively. The least significant differences at for and Cmax were , respectively. Though the plasma clarithromycin concentrations of Hanmi clarithromycin were higher than those of at all observed times, the bioavailability of Hanmi clarithromycin appeared to be bioequivalent with that of . The Ka, Kel, , Vd/F and Cl/F of the Hanmi clarithromycin were , respectively, and those of , respectively. There were no statistically significant differences between two drugs in all pharmacokinetic parameters.