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- Title
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.
- Authors
Gäckler, Anja; Dolff, Sebastian; Rohn, Hana; Korth, Johannes; Wilde, Benjamin; Eisenberger, Ute; Mitchell, Anna; Kribben, Andreas; Witzke, Oliver
- Abstract
<bold>Background: </bold>The influence of pre- or postprandial administration on pharmacokinetics of cyclosporine is supposed to be less in gel-based formulations than in microemulsions. This study was designed to investigate the influence of a high-fat meal on the pharmacokinetic profile of the two cyclosporine containing formulations Ciclosporin Pro (gel-based emulsion) and Sandimmun®Optoral (microemulsion) in renal transplant recipients.<bold>Methods: </bold>A randomized, open-label, repeated-measurement, comparative phase IV trial was conducted with two sequence groups for nutrition condition (fasting→fed, fed→fasting) and two treatment phases (Sandimmun® Optoral → Ciclosporin Pro), each covering both nutrition conditions. Primary pharmacokinetic variable of interest was the reduction of bioavailability due to high-fat food compared to fasting conditions measured by the difference D of ln-transformed bioavailability variables (AUCSS, τ, Css, max, und Css, min).<bold>Results: </bold>A nutrition effect was found for both study medications with respect to the parameters AUCSS, τ and CSS, max, but not to CSS, min. The reduction of bioavailability caused by high-fat food was not significantly different for Sandimmun®Optoral and Ciclosporin Pro.<bold>Conclusions: </bold>An effect of high-fat breakfast prior to the morning dose on AUCSS, τ and CSS, max was found for Sandimmun® Optoral and for Ciclosporin Pro. Trough level monitoring did not capture ingestion-related variability. Conversion to Ciclosporin Pro seems to be safe with regard to intra-individual pharmacokinetic variability.<bold>Trial Registration: </bold>EudraCT No. 2009-011354-18 (29th April 2019).
- Subjects
BIOAVAILABILITY; NOVARTIS AG; KIDNEY transplantation; CYCLOSPORINE; MICROEMULSIONS; NUTRITION
- Publication
BMC Nephrology, 2019, Vol 20, Issue 1, pN.PAG
- ISSN
1471-2369
- Publication type
journal article
- DOI
10.1186/s12882-019-1340-z