Cancer Research Journal

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Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon

Received: 22 October 2015    Accepted: 04 November 2015    Published: 08 December 2015
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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.

DOI 10.11648/j.crj.20150306.11
Published in Cancer Research Journal (Volume 3, Issue 6, November 2015)
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), 2024. Published by Science Publishing Group

Keywords

Capecitabine, Generic, Pharmacokinetic, Bioequivalence, Cancer, Colon

References
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[5] O’Shaughnessy JA, Blum J, Moiseyenko V, et al. Randomized, open-label, phase II trial of oral capectibine (Xeloda) vs a reference arm intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 2001, 12: pp 1247-1254.
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Author Information
  • Nanopharmacia Diagnóstica, Mexico City, Mexico

  • Research, Science and International Technology, Mexico City, Mexico

  • Research, Science and International Technology, Mexico City, Mexico

  • Research, Science and International Technology, Mexico City, Mexico

  • Clinical Research Department, Laboratorios PiSA, S.A. de C.V, Mexico City, Mexico

  • Clinical Research Department, Laboratorios PiSA, S.A. de C.V, Mexico City, Mexico

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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

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    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

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    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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  • @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://download.sciencepg.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}
    }
    

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    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
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    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
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