Bioequivalence and Bioavailability Forum

❝ To capecitabine, ANVISA recommends strength 150 mg and healthy volunteers.

❝ 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)?

1. 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
   
2. Please see this thread.
   The active metabolites are shifted to the right, so your WO is not enough, I'd expect significant period effect
   
3. I think it is going to be a fed study in accordance with leaflet, right? How to perform it each hour?