Average bioequivalence of generic clarithromycin tablets in healthy thai male volunteers

The objective of this study was to assess bioequivalence of 500-mg clarithromycin tablets in 24 healthy 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 analyzed by using a validated method using high performance liquid chromatography (HPLC) with electrochemical detection. The time to reach the maximal concentration (tmax,h), the peak concentration (Cmax,ng/ml) and the area under the curve (AUC0–∞,ng h/ml) of the Reference and Test formulations were 2.1±0.7 vs 2.1±0.7, 2474±702 vs 2559±744 and 15803±6120 vs 17683±6650, respectively. Relative bioavailability was 1.12. The 90% confidence interval (90% CI) of Cmax and AUC0–∞ were 95.6–110.8% and 3.5–122.0%, respectively. Bioequivalence between the test and reference preparation can be concluded. Copyright © 2003 John Wiley & Sons, Ltd.