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Dear Sirs
We are planning to conduct a bioequivalence study for Capecitabine.
I would appreciate any comments concerning the possibility of
conducting this study with healthy volunteers.
We are also planning to establish BE based only on the active
metabolite 5-fluorouracil (5-FU).
Thanks in advance,
Jaime Ilha
Galeno Research
Campinas, Brazil
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The following message was posted to: PharmPK
Do you really plan to conduct trial of a cytotoxic agent in healthy
volunteers? It is not ethical with such drugs.
Sincerely
Dr Brigitte Tranchand
EA3738 Chemotherapy Targeting in Oncology
Faculte de Medecine Lyon-Sud
BP 12
69921 Oullins Cedex
France
email : Brigitte.Tranchand.-at-.adm.univ-lyon1.fr
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The following message was posted to: PharmPK
I completely agree with Brigitte Tranchand.
I don't know which Ethical Committee could approve such a study.
Sincerely
Elena Strocchi
--
Elena Strocchi
Laboratorio di Farmacocinetica e Metabolismo
Dipartimento di Chimica Organica
Universita di Bologna
Viale Risorgimento, 4 - 40136 Bologna
E-mail strocchi.at.ms.fci.unibo.it
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Dear Jaime Ilha,
As Capecitabine is a cytotoxic you have to do the study on patients
only. And one more thing is that, for this study you needed a high
sample size of nearly 90 subjects (as we too planned the study)
Thank you.
Regards,
Raghavendra
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Dear Jaime,
I think you can go ahead with the conduct of the study but dose
(multiple dose may not be allowed) has to be taken into consideration.
Anti-cancer drugs though cytotoxic, they can be used to test BE
usually on single dose studies. With Capecitabine, you may have to
estimate both the Drug and its active metabolite 5-FU.
Hope this helps,
Regards,
Santosh Tata, BS (Pharm. Sci),
Bioanalytical Laboratory,
Clinsys Clinical Research Ltd,
C-46, Sector-62, NOIDA,
Uttar Pradesh, India.
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Dear Santosh,
I would be very grateful if you could provide some reference. I believe
cytotoxics cannot be used in normal subjects, neither single nor
multiple
doses.
Regards,
Dr Srinivas Sidgiddi
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Dear Dr. Srinivas,
I am perplexed for a while whether I have posted wrongly. I remembered
a discussion on the same forum that appeared a few years ago (while I
worked on Oncology at IICT, Hyd). I myself worked on Imatinib BE
study. Here are some references and links that can possibly help us.
Also one doubt is whether Alkylating agents can be used for BE studies.
http://www.boomer.org/pkin/PK05/PK2005077.html
Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005: 3163
http://gicancers.asco.org/ASCO/Abstracts+&+Virtual+Meeting/Abstracts?&vmview=abst_detail_view&confID=23&abstractID=102893
Regards,
Santosh Tata, BS (Pharm. Sci),
Bioanalytical Laboratory,
Clinsys Clinical Research Ltd,
C-46, Sector-62, NOIDA,
Uttar Pradesh, India.
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5-FU BE Study can only be permitted in patients with advanced cancer.
Regards,
Santosh Tata, BS (Pharm. Sci),
Bioanalytical Laboratory,
Clinsys Clinical Research Ltd,
C-46, Sector-62, NOIDA,
Uttar Pradesh, India.
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