| Popis: |
To evaluate the average bioequivalence of two formulations of 500 mg clarithromycin tablets in 24 healthy Thai male volunteers.In a randomized, single dose, fasting state, two-period, crossover study design with a 1-week washout period, each subject received a 500 mg clarithromycin tablet. Plasma samples were collected over a 24-h period after administration and were analysed by using a validated HPLC-ECD method. Pharmacokinetic parameters were determined by using non-compartmental analysis.The time to reach the maximal concentration (tmax, h), the peak concentration (Cmax, ng/mL) and the area under the curve (AUC0- infinity, ng h/mL) of the Reference and Test formulations were 2.0 +/- 0.9 vs. 1.8 +/- 1.1, 3018 +/- 841 vs. 3014 +/- 752 and 23142 +/- 7348 vs. 22810 +/- 6027, respectively. The 90% confidence interval of Cmax and AUC0- infinity were 90.6-109.4 and 89.6-110.1%.Bioequivalence between the Test and Reference formulation can be concluded. |
