Human bioequivalence study of clarithromycin from two tablet formulations after single oral administration

Objective: The objective of this study was to compare the relative bioavail ability and bioequivalence of a test (Claromycin (R), GA Pharmaceuticals) a nd a reference (Klaricid (R), Abbott) tablet containing 500mg clarithromyci n in healthy volunteers under fasting conditions. Methods: This was a nonblinded, single-dose, randomised, two-period, crosso ver study in 16 healthy volunteers conducted under fasting conditions. Plas ma samples were analysed for clarithromycin by a validated high performance liquid chromatography assay with electrochemical detection. Results: One volunteer did not receive the reference tablet. The parametric 90% confidence intervals of the geometric mean values of the test/referenc e ratios analysed for 16 participants were 84.2 to 111.6% (point estimate 9 7.3%) for the area under the plasma concentration-time curve for time zero to infinity (AUC(0-infinity)), 82.2 to 117.6% (point estimate 98.3 %) for t ime zero to time t (AUC(0-t)), and 74.4 to 142.9% (point estimate 103.1%) f or peak plasma concentration (C-max). No statistically significant differen ces were found between the formulations for the time to reach C-max (t(max) and elimination half-life values. When the results were analysed for 15 pa rticipants, the 90% confidence intervals were 84.1 to 111.9% for AUC(0-infi nity), 82.8 to 119.1% for AUC(0-t) and 74.1 to 143.6% for C-max. Conclusions: From the results of this study, it is concluded that the two t ablet preparations of clarithromycin are bioequivalent in both the extent a nd the rate of absorption.