Skip to main content

Table 4 Difference between Ciclosporin Pro and Sandimmun® Optoral in ln-transformed nutrition effects (PP, n = 21)

From: Randomized, open-label, comparative phase IV study on the bioavailability of Ciclosporin Pro (Teva) versus Sandimmun® Optoral (Novartis) under fasting versus fed conditions in patients with stable renal transplants

PK parameter DCiclosporin Pro – DSandimmun Optoral Mean [SD] DCiclosporin Pro – DSandimmun Optoral [97.5% CI] Testing of H0*
t-value p-value**
CSS, max 0.1266 [0.6248] [−0.1578; Infinity] 0.93 0.1820
AUCSS, τ 0.0494 [0.2850] [−0.0803; Infinity] 0.79 0.2180
CSS, min −0.0464 [0.3271] [−0.1953; Infinity] − 0.65 0.7384
  1. Bold entries are significant
  2. * Testing of H0 (0 ≥ DCiclosporin Pro - DSandimmun Optoral) by means of the one-sided paired t-test (α = 0.025)
  3. ** lowest (one-sided) significance level, for which the null hypothesis could be rejected