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Table 5 Difference of ln-transformed PK variables between high-fat versus fasting condition (PP; n = 21) for Ciclosporin Pro and Sandimmun® Optoral

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
Mean [SD]
DCiclosporin Pro
[95% CI]
Testing of H0*
t-value p-value**
AUCSS, τ −0.1252 [0.2008] [−0.2166; − 0.0338] −2.86 0.0097
CSS, max −0.3916 [0.4371] [− 0.5906; − 0.1927] −4.11 0.0005
CSS, min − 0.0690 [0.2094] [− 0.1644; 0.0263] −1.51 0.1465
PK parameter DSandimmun Optoral
Mean [SD]
DSandimmun Optoral
[95% CI]
Testing of H0*
t-value p-value**
AUCSS, τ −0.1747 [0.1443] [−0.2403; − 0.1090] −5.55 <.0001
CSS, max −0.5183 [0.3148] [− 0.6616; − 0.3750] −7.55 <.0001
CSS, min − 0.0227 [0.1789] [− 0.1041; 0.0588] −0.58 0.5681
  1. * Testing of H0 (DCiclosporin Pro = 0) by means of the two-sided paired t-test
  2. ** lowest (two-sided) significance level, for which the null hypothesis could be rejected