Capecitabine: study with healthy volunteers [BE/BA News]
Dear Mauricio,
I think their suggestion is based on this article.
I would not do that.
❝ To capecitabine, ANVISA recommends strength 150 mg and healthy volunteers.
I think their suggestion is based on this article.
❝ Can I imagine a replicate study (partial or full) assuming a total dose of 450 mg (3x150 mg) to 600 mg (4x150 mg), respectively, to each subject in a short time between the periods (WO ~ 1 hour)?
I would not do that.
- From the article:
The dose administered to the healthy volunteer was a single administration of one tablet of 150 mg, which represents less than 4% of the dose one patient would receive in one day
In your case that's 12-16%. Since the goal of your project is not to investigate the toxicity, EC could reasonably refuse it due to unproven safety
- Please see this thread.
The active metabolites are shifted to the right, so your WO is not enough, I'd expect significant period effect
- I think it is going to be a fed study in accordance with leaflet, right? How to perform it each hour?
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Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- EMA: 7 product-specific guidances adopted Helmut 2015-07-07 14:10 [BE/BA News]
- EMA: 7 product-specific guidances adopted mittyri 2015-07-08 13:55
- capecitabine ≠ NTID; reference-scaling Helmut 2015-07-08 14:59
- Tadalafil: Similar technology and formulas as the originator luvblooms 2015-07-10 07:24
- Tadalafil: Similar technology and formulas as the originator mmw 2015-07-17 11:38
- 9 new just published Ohlbe 2016-04-07 19:08
- Five new drafts published Helmut 2016-08-23 15:09
- New product specific guidance of Fidaxomicin Mahesh M 2016-08-24 05:58
- EMA: 7 product-specific guidances adopted (Capecitabine) Mauricio Sampaio 2016-12-12 19:33
- Capecitabine: study with healthy volunteersmittyri 2016-12-14 12:39
- EMA: 7 product-specific guidances adopted mittyri 2015-07-08 13:55