Objectives: This study aims to test the therapeutic equivalence and convertibility of two cyclosporine microemulsion formulations: reference preparation vs. generic microemulsion cyclosporine. Methods: A multicentric randomized study was carried out among 25 heart transplant patients with at least a year of progression and under steady immunosuppressive therapy. The study protocol selected was the X Latin, where each patient is his/her own control and includes the crossover of the study formulations among them. After signing the informed consent form, patients underwent through a series of laboratory and clinical examinations. After randomization, the patients were assigned to receive either the reference formulation or generic cyclosporine. Every 15 days, in a total of four rounds, patients were submitted to laboratory tests, clinical evaluation and crossover of cyclosporine formulations. As a whole, there were two observation periods with two crossover series per period. Results: The pharmacokinetic parameters of the two formulations show no statistically significant differences.
In addition, clinical and side effects were very similar. Conclusions: These results confirm the full convertibility between reference and generic microemulsion cyclosporines
Keywords: Cyclosporine microemulsion. Pharmacokinetic. Reference microemulsion cyclosporine. Generic microemulsion cyclosporine. Convertibility.;