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A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients
Author(s) -
Alloway R. R.,
Sadaka B.,
TrofeClark J.,
Wiland A.,
Bloom R. D.
Publication year - 2012
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2012.04174.x
Subject(s) - tacrolimus , bioequivalence , pharmacokinetics , medicine , cmax , urology , pharmacology , crossover study , trough level , kidney transplantation , kidney transplant , kidney , transplantation , pathology , alternative medicine , placebo
Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open‐label, randomized, two‐period (14 days per period), two‐sequence, crossover and steady‐state pharmacokinetic study was undertaken to compare twice‐daily generic tacrolimus (Sandoz) versus reference tacrolimus (Prograf®) in stable renal transplant patients. AUC 0–12h and peak concentration (C max ) were calculated from 12 h pharmacokinetic profiles at the end of each period (days 14 and 28). Of 71 patients enrolled, 68 provided evaluable pharmacokinetic data. The ratios of geometric means were 1.02 (90% CI 97–108%, p = 0.486) for AUC 0–12h and 1.09 (90% CI 101–118%, p = 0.057) for C max . Mean (SD) C 0 was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28. Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28. These data indicate that generic tacrolimus (Sandoz) has a similar pharmacokinetic profile to the reference drug and is bioequivalent in kidney transplant recipients according to US Food and Drug Administration and European Medicines Agency guidelines.