Popis: |
A bioequivalence study of Gomcillin™ capsules (DAEWOONG Pharmaceutical Co., Korea) to Famoxin™ capsules (Dong Wha Pharm. Ind. Co., Korea) was conducted according to the guideline of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the amoxicillin dose of 500 ㎎ in a 2×2 crossover study. There was a one-week wash out period between the doses. Plasma concentrations of amoxicillin were monitored by a high-performance liquid chromatography for over a period of 8 hours after the administration. AUCt (the area under the plasma concentration-time curve from time zero to 8 hr) was calculated by the linear trapezoidal rule 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 variance was carried out using logarithmically transformed AUCt and C_(max). No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly per-formed. The 90% confidence intervals of the AUCt ratio and the C_(max) ratio for Gomcillin™/Famoxin™ were log0.91 ~ log 1.03 and log0.93 - log l .10, respectively. These values were within the acceptable bioequivalence intervals of log 0.80 ~ log 1.25. Thus, our study demonstrated the bioequivalence of Gomcillin™ and Famoxin™ with respect to the rate and extent of absorption. |