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Verfasst von:Huppertz, Andrea [VerfasserIn]   i
 Bollmann, Johanna [VerfasserIn]   i
 Behnisch, Rouven [VerfasserIn]   i
 Bruckner, Thomas [VerfasserIn]   i
 Zorn, Markus [VerfasserIn]   i
 Burhenne, Jürgen [VerfasserIn]   i
 Haefeli, Walter E. [VerfasserIn]   i
 Czock, David [VerfasserIn]   i
Titel:Differential effect of a continental breakfast on tacrolimus formulations with different release characteristics
Verf.angabe:Andrea Huppertz, Johanna Bollmann, Rouven Behnisch, Thomas Bruckner, Markus Zorn, Jürgen Burhenne, Walter E. Haefeli, and David Czock
Jahr:2021
Umfang:9 S.
Illustrationen:Illustrationen
Fussnoten:Gesehen am 11.09.2023
Titel Quelle:Enthalten in: Clinical pharmacology in drug development
Ort Quelle:Oxford [u.a.] : Wiley-Blackwell, 2012
Jahr Quelle:2021
Band/Heft Quelle:10(2021), 8, Seite 899-907
ISSN Quelle:2160-7648
Abstract:Food reduces tacrolimus bioavailability after immediate-release tacrolimus (IR-Tac) and after a new prolonged-release tacrolimus formulation (PR-Tac), when using a high-fat breakfast, but the effects of a continental breakfast on PR-Tac are unknown. In an open-label, 4-phase, randomized, 2-sequence, crossover pharmacokinetic trial, 36 healthy volunteers (18 females) received single 5-mg tacrolimus doses as PR-Tac and as IR-Tac fasted or with a standardized continental breakfast. Tacrolimus pharmacokinetics were analyzed using noncompartmental methods and mixed-model analysis of variance. The continental breakfast significantly decreased average tacrolimus exposure (area under the plasma concentration-time curve) with both preparations (IR-Tac, 67%; 90% confidence interval [CI], 59%-75%; P < .01; and PR-Tac, 79%; 90%CI, 70%-89%; P < .01) with a nonsignificant difference between both preparations (P = .10). The maximum concentration (Cmax) and the time to maximum concentration (tmax) were significantly affected only after IR-Tac (Cmax IR-Tac, 39%; 90%CI, 34%-45%; P < .01; and PR-Tac, 87%; 90%CI, 76%-101%; P = .11; tmax IR-Tac, 212%, 90%CI, 179%-252%; P < .01; and PR-Tac, 101%; 90%CI, 86%-120%; P = .89), which was significantly different between both preparations (P < .01). Considering switching from IR-Tac to PR-Tac, predicted dose requirements differed according to the timing of drug intake in relation to food. In conclusion, a continental breakfast decreased average tacrolimus exposure of both preparations to a similar extent. Cmax and tmax were affected only after IR-Tac. The effect of a standardized continental breakfast on PR-Tac was considerably smaller than previously reported effects of a high-fat breakfast on PR-Tac.
DOI:doi:10.1002/cpdd.924
URL:kostenfrei: Volltext: https://doi.org/10.1002/cpdd.924
 kostenfrei: Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1002/cpdd.924
 DOI: https://doi.org/10.1002/cpdd.924
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:continental breakfast
 food effects
 immediate-release tacrolimus
 pharmacokinetics
 prolonged-release tacrolimus
K10plus-PPN:1859251889
Verknüpfungen:→ Zeitschrift
 
 
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