Comparative bioavailability of two oral nimodipine formulations after administration to 24 healthy volunteers

Objective and Study Participants: To investigate the comparative bioavailability of two oral 30mg film-coated tablet formulations of nimodipine, Brainal(R) (test formulation) and Nimotop(R) (reference formulation) after replicate administration of a single 60mg dose (2 x 30mg) of both formulations to 24 healthy volunteers. Results: The data obtained in this study demonstrated the bioequivalence of the two formulations when the individual bioequivalence approach, which takes into account both the intraindividual and the interindividual variances, was applied. The assessment of individual bioequivalence was based on the result of the upper 90% one-sided confidence limits: 2.47 for maximum plasma concentration (C-max) and 2.77 for area under the plasma concentration-time curve (AUC(0-infinity)), both lower than the critical value, F-cr = 4, thus showing the bioequivalence between the two formulations. Conclusion: The results indicate the bioequivalence and goad tolerability of both nimodipine formulations. The application of the individual bioequivalence approach shows the bioequivalence of the two nimodipine formulations.