Study on relative bioavailability of aniracetam capsules

Aim The relative bioavailabilities of aniracetam capsules were studied. Methods The blood concentrations of the main metabolite of aniracetam, N anisoyl GABA(ABA), were determined by RP HPLC after a single oral dose of 400 mg aniracetam of test(capsules) or reference(capsules) drugs was given separately to 12 volunteers in an open randomized cross over test. Statistical software's 3p87 were used for the calculation of results. Results After taking a single oral dose of 400 mg aniracetam test capsules and reference capsules, thd AUC 0～t of aniracetam of the two formulations were ( 781.0 ± 169.5) μg ·min·ml -1 and ( 792.3 ± 156.6) μg ·min·ml -1 ; t max were ( 40.9 ± 9.7) min and ( 37.3 ± 11.5) min ; c max of ABA were ( 10.4 ± 3.0) μg ·ml -1 and ( 10.5 ± 3.0) μg ·ml -1 . The results of statistical analysis showed that there were no significant difference in the AUC 0～t ,t max and c max of ABA between the formulations ( P0.05 ). The relative bioavailability of aniracetam capsule was ( 99.4 ± 14.4 )%. Conclusion The two aniracetam capsules were bioequivalent.