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Table 6 Ratio of non-transformed PK variables of Ciclosporin Pro to Sandimmun® Optoral under fasting condition (top) and under high-fat conditions (bottom) (PP; n = 18)

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

  BioavailabilityCiclo Pro/BioavailabilityOptoral
Geometric mean
BioavailabilityCiclo Pro/BioavailabilityOptoral
[90% CI]
PK parameter (fasting)
 AUCSS, τ 0.940 [0.868; 1.018] a
 CSS, max 0.863 [0.745; 0.999]
 CSS, min 1.011 [0.922; 1.108] b
PK parameter (high-fat)
 AUCSS, τ 1.034 [0.972; 1.099] b
 CSS, max 1.082 [0.930; 1.260]
 CSS, min 0.955 [0.881; 1.035] a
  1. a CI included in [0.80; 1.25], but not in [0.90; 1.11]
  2. b CI included in [0.90; 1.11]