Please use this identifier to cite or link to this item: https://hdl.handle.net/1/148
Title: Assessment of the Bioequivalence of a Generic Cyclosporine A by a Randomized Controlled Trial in Stable Renal Recipients
Authors: Hibberd, Adrian D ;Trevillian, Paul R ;Roger, Simon D ;Wlodarczyk, John H ;Stein, Ann M ;Bohringer, Elizabeth G ;Milson-Hawke, Sally M 
Issue Date: Mar-2006
Source: Volume 81, Issue 5, pp. 711-717
Journal title: Journal of Transplantation
Abstract: BACKGROUND: The aim of this study was to determine the bioequivalence of Cysporin, a generic cyclosporine A, compared with Neoral in stable renal transplant recipients. METHODS: Study design consisted of an open label, two-way crossover, randomized controlled trial of Cysporin versus Neoral in stable renal transplant recipients. In all, 33 patients were enrolled; 31 were randomized and 28 were evaluable. AUCs(0-12) were done on day 14 and 28; C(0) and C(2) were done on days 0, 7, 21 and 35. Dose conversion was 1:1. Outcome measures for serum cyclosporin A concentrations expressed as the mean+/-SD were AUC(0-12) (microg x hr/L), C(max) (microg/L), C(2) (microg/L), T(max) (hr) and T(1/2) (hr). Mean and 90% CI of the ratio Cysporin/Neoral of log-transformed data were calculated using a general linear model. RESULTS: The main pharmacokinetic features were: AUC(0-12): Cysporin 3495+/-1319, Neoral 3853+/-1378 (P<0.05); C(max): Cysporin 755+/-301, Neoral 881+/-368 (P<0.05); C(2): Cysporin 613+/-235, Neoral 672+/-255 (P>0.05); T(max): Cysporin 1.9+/-0.8, Neoral 1.4+/-0.6 (P<0.005); and T1/2: Cysporin 8.8+/-4.3, Neoral 8.7+/-6.2 (P>0.05). Estimated ratios of Cysporin/Neoral were: AUC 0.93 (90% CI 0.88-0.98; P<0.05); C(max) 0.88 (90% CI 0.80-0.97; P<0.05); and T(max) 1.32 (90% CI 1.14-1.53; P<0.005). CONCLUSIONS: Both the extent and rate of absorption of Cysporin are significantly less than those of Neoral. The 90% CI for the ratios of Cysporin/Neoral for AUC and C(max) lie within 0.80-1.25. Hence in this clinical context Cysporin is pharmacologically bioequivalent with Neoral. This study illustrates the importance of testing bioequivalence of generic cyclosporine A products in transplant recipients not healthy volunteers.
URI: https://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/148
DOI: 10.1097/01.tp.0000181198.98232.0c
Pubmed: http://www.ncbi.nlm.nih.gov/pubmed/16534473
ISSN: 0041-1337
Publicaton type: Journal Article
Keywords: Kidney Transplant
Drug Therapy
Study or Trial: Randomized Controlled Clinical Trial/Controlled Clinical Trial
Appears in Collections:Renal Medicine

Show full item record

Page view(s)

12
checked on Feb 3, 2023

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.