Capecitabine is an orally administered chemotherapeutic agent used in the treatment of numerous cancers including colon, colorectal, ovarian, breast and pancreatic. Considering the importance of generic drugs in Health Care Systems, it is essential that its quality, safety and efficacy be compared with the corresponding innovator product. The objective of the study was to compare the pharmacokinetics and relative bioequivalence between two tablet (500 mg) formulations of capecitabine in Mexican patients with cancer of colon. The study was designed as open, prospective, randomized, two-way, crossover bioequivalence trial. A single oral dose of 2000 mg capecitabine was administered on two separate days to 24 patients. After each administration, serial blood samples were collected for up 8 hr. The washout between the two administrations was 3 days. Capecitabine was determined in plasma using LC/MS-MS. No statistically significant differences in Cmax, AUC0-t, and AUC0-α were found between the test and innovator formulations. Both products were well tolerated by the patients, with no serious adverse events. The generic capecitabine was pharmacokinetic bioequivalent with the innovator formulations.
| Published in | Cancer Research Journal (Volume 3, Issue 6) |
| DOI | 10.11648/j.crj.20150306.11 |
| Page(s) | 110-114 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2015. Published by Science Publishing Group |
Capecitabine, Generic, Pharmacokinetic, Bioequivalence, Cancer, Colon
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APA Style
Ruiz-García Erika Betzabe, Mancera-Reyes Víctor Manuel, Bustillos-Ventura Rafael, Cárdenas José Manuel, Canales-Vázquez Emmanuel, et al. (2015). Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon. Cancer Research Journal, 3(6), 110-114. https://doi.org/10.11648/j.crj.20150306.11
ACS Style
Ruiz-García Erika Betzabe; Mancera-Reyes Víctor Manuel; Bustillos-Ventura Rafael; Cárdenas José Manuel; Canales-Vázquez Emmanuel, et al. Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon. Cancer Res. J. 2015, 3(6), 110-114. doi: 10.11648/j.crj.20150306.11
AMA Style
Ruiz-García Erika Betzabe, Mancera-Reyes Víctor Manuel, Bustillos-Ventura Rafael, Cárdenas José Manuel, Canales-Vázquez Emmanuel, et al. Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon. Cancer Res J. 2015;3(6):110-114. doi: 10.11648/j.crj.20150306.11
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Download@article{10.11648/j.crj.20150306.11,
author = {Ruiz-García Erika Betzabe and Mancera-Reyes Víctor Manuel and Bustillos-Ventura Rafael and Cárdenas José Manuel and Canales-Vázquez Emmanuel and Meixueiro-Montes de Oca Raúl},
title = {Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon},
journal = {Cancer Research Journal},
volume = {3},
number = {6},
pages = {110-114},
doi = {10.11648/j.crj.20150306.11},
url = {https://doi.org/10.11648/j.crj.20150306.11},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.crj.20150306.11},
abstract = {Capecitabine is an orally administered chemotherapeutic agent used in the treatment of numerous cancers including colon, colorectal, ovarian, breast and pancreatic. Considering the importance of generic drugs in Health Care Systems, it is essential that its quality, safety and efficacy be compared with the corresponding innovator product. The objective of the study was to compare the pharmacokinetics and relative bioequivalence between two tablet (500 mg) formulations of capecitabine in Mexican patients with cancer of colon. The study was designed as open, prospective, randomized, two-way, crossover bioequivalence trial. A single oral dose of 2000 mg capecitabine was administered on two separate days to 24 patients. After each administration, serial blood samples were collected for up 8 hr. The washout between the two administrations was 3 days. Capecitabine was determined in plasma using LC/MS-MS. No statistically significant differences in Cmax, AUC0-t, and AUC0-α were found between the test and innovator formulations. Both products were well tolerated by the patients, with no serious adverse events. The generic capecitabine was pharmacokinetic bioequivalent with the innovator formulations.},
year = {2015}
}
TY - JOUR T1 - Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon AU - Ruiz-García Erika Betzabe AU - Mancera-Reyes Víctor Manuel AU - Bustillos-Ventura Rafael AU - Cárdenas José Manuel AU - Canales-Vázquez Emmanuel AU - Meixueiro-Montes de Oca Raúl Y1 - 2015/12/08 PY - 2015 N1 - https://doi.org/10.11648/j.crj.20150306.11 DO - 10.11648/j.crj.20150306.11 T2 - Cancer Research Journal JF - Cancer Research Journal JO - Cancer Research Journal SP - 110 EP - 114 PB - Science Publishing Group SN - 2330-8214 UR - https://doi.org/10.11648/j.crj.20150306.11 AB - Capecitabine is an orally administered chemotherapeutic agent used in the treatment of numerous cancers including colon, colorectal, ovarian, breast and pancreatic. Considering the importance of generic drugs in Health Care Systems, it is essential that its quality, safety and efficacy be compared with the corresponding innovator product. The objective of the study was to compare the pharmacokinetics and relative bioequivalence between two tablet (500 mg) formulations of capecitabine in Mexican patients with cancer of colon. The study was designed as open, prospective, randomized, two-way, crossover bioequivalence trial. A single oral dose of 2000 mg capecitabine was administered on two separate days to 24 patients. After each administration, serial blood samples were collected for up 8 hr. The washout between the two administrations was 3 days. Capecitabine was determined in plasma using LC/MS-MS. No statistically significant differences in Cmax, AUC0-t, and AUC0-α were found between the test and innovator formulations. Both products were well tolerated by the patients, with no serious adverse events. The generic capecitabine was pharmacokinetic bioequivalent with the innovator formulations. VL - 3 IS - 6 ER -
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