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An individual bioequivalence approach to compare the intrasubject variability of two ciclosporin formulations, SangCya and Neoral
Canafax, DM., Irish, W., Moran, HB., Squiers, E., Levy, R., Pouletty, P., First, MR., & Christians, U. (1999). An individual bioequivalence approach to compare the intrasubject variability of two ciclosporin formulations, SangCya and Neoral. Pharmacology, 59(2), 78-88.
A novel bioequivalence testing approach was used to determine intrasubject variability and switchability of two ciclosporin formulations, SangCya (test) and Neoral (reference). Twenty healthy volunteers were enrolled into a single-dose, randomized, open-label, 4-period, 2-sequence study with a crossover replicate design. Subject-by-formulation interaction variances were compared using a mixed effects linear model. Intrasubject variability for ln AUC(0-infinity) and ln C(max) of SangCya and Neoral were not significantly different. The 95% confidence intervals of the intrasubject variability of AUC(0-infinity) (0.94) and C(max) (1.28) as determined using the bootstrap nonparametric percentile method (n = 2,000) were below the individual bioequivalence limit estimated at 2.25. We concluded equivalent intrasubject variability of ciclosporin pharmacokinetics and switchability between SangCya and Neoral