RENAL-TRANSPLANT PATIENTS; CYCLOSPORINE-A; CONSUPREN; FORMULATIONS; PHARMACOKINETICS; LYMPHOCYTE; THERAPY; LEVEL; SAFE

Methods used to define bioequivalence as stated by the FDA are (1) pharmacokinetic (PK) studies in healthy volunteers, (2) comparative clinical trials, and (3) pharmacodynamic (PD) studies (bioactivity). We undertook a comparative bioavailability study of Equoral (IVAX, USA) Neoral (Novartis, USA), and Neoral (Novartis UK). The area under curve (AUC), AUC extrapolated to infinity (AUC0-inf), rate of absorption (Tmax), extent of absorption (Cmax), half time (t1/2) of Equoral and Neoral were all within the 90% confidence interval of 80% to 125% boundaries. A comparative multicenter clinical trial in stable renal transplant patients included 70 patients.. In a controled switch, fixed-dose study, both Equoral and Neoral achieved the same concentration in the lymphocytes and caused the same degree of lymphocyte count reduction. The results suggests that Neoral and Equoral are switchable.