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A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients
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 t...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Inc
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3472020/ https://www.ncbi.nlm.nih.gov/pubmed/22759200 http://dx.doi.org/10.1111/j.1600-6143.2012.04174.x |
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author | Alloway, R R Sadaka, B Trofe-Clark, J Wiland, A Bloom, R D |
author_facet | Alloway, R R Sadaka, B Trofe-Clark, J Wiland, A Bloom, R D |
author_sort | Alloway, R R |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-3472020 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Blackwell Publishing Inc |
record_format | MEDLINE/PubMed |
spelling | pubmed-34720202012-10-18 A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients Alloway, R R Sadaka, B Trofe-Clark, J Wiland, A Bloom, R D Am J Transplant Brief Communications 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. Blackwell Publishing Inc 2012-10 /pmc/articles/PMC3472020/ /pubmed/22759200 http://dx.doi.org/10.1111/j.1600-6143.2012.04174.x Text en © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons http://creativecommons.org/licenses/by/2.5/ Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. |
spellingShingle | Brief Communications Alloway, R R Sadaka, B Trofe-Clark, J Wiland, A Bloom, R D A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients |
title | A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients |
title_full | A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients |
title_fullStr | A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients |
title_full_unstemmed | A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients |
title_short | A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients |
title_sort | randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients |
topic | Brief Communications |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3472020/ https://www.ncbi.nlm.nih.gov/pubmed/22759200 http://dx.doi.org/10.1111/j.1600-6143.2012.04174.x |
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