Bioequivalence of Raberazole enteric-coated tablets in healthy volunteers

AIM: To compare the relative bioavailability of the Raberazole preparations-sample tablets and reference tablets. METHODS: Raberazole concentrations in plasma of 18 healthy young volunteers were determined after a single oral dose (20 mg) of two Raberazole preparations were given respectively to 18 voluteers in an open randomized standard two-stage crossover self-control test. The Raberazole concentration in plasma was assayed by the HPLC method. The pharmacokinetic parameters were calcu-lated with 3p97 program by computer. RESULTS: Time for peak concentration (Tmax) was (4.3±1.4) and (4.3±1.1) h, half life time (T1/2) was (1.5±0.4) and (1.4±0.4) h, peak concentration (Cmax) was (505±169) and (466±182) μg/L, 0→12 h area under the curve [AUC(0→12 h)] was (1365±454) and (1263±485) μg·h /L, 0→∞ area under the curve (AUC0→∞) was (1399±471) and (1295±486) μg·h/L. The relative bioavailability of Raberazole sample tablets compared with the contrast tablets was 111.1%. CONCLUSION: The two preparations are bioequivalent.