Human Bioequivalence Study of Clarithromycin from Two Tablet Formulations after Single Oral Administration.

Abstract

The objective of this study was to compare the relative bioavailability and bioequivalence of a test (Claromycin®, GA Pharmaceuticals) and a reference (Klaricid®, Abbott) tablet containing 500mg clarithromycin in healthy volunteers under fasting conditions. This was a nonblinded, single-dose, randomised, two-period, crossover study in 16 healthy volunteers conducted under fasting conditions. Plasma samples were analysed for clarithromycin by a validated high performance liquid chromatography assay with electrochemical detection. One volunteer did not receive the reference tablet. The parametric 90% confidence intervals of the geometric mean values of the test/reference ratios analysed for 16 participants were 84.2 to 111.6% (point estimate 97.3%) for the area under the plasma concentration-time curve for time zero to infinity (AUC0-∞), 82.2 to 117.6% (point estimate 98.3%) for time zero to time t (AUC0-t), and 74.4 to 142.9% (point estimate 103.1%) for peak plasma concentration (Cmax). No statistically significant differences were found between the formulations for the time to reach Cmax (tmax) and elimination half-life values. When the results were analysed for 15 participants, the 90% confidence intervals were 84.1 to 111.9% for AUC0-∞, 82.8 to 119.1% for AUC0-t, and 74.1 to 143.6% for (Cmax) From the results of this study, it is concluded that the two tablet preparations of clarithromycin are bioequivalent in both the extent and the rate of absorption.