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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