Dipyrone design [Design Issues]

posted by Nelson Wagner – 2013-05-03 03:27 (4807 d 20:14 ago) – Posting: # 10532
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Dear all:

We have to perform a BE study of dipyrone 300mg FCT (this is the only strenght available from the sponsor) using 500 mg FCT as reference.

Dipyrone metabolism is not linear above 750mg, but there is no studies performed in the 300-500 range, so I don't know if the metabolism is saturated under 500mg.

Is correct the approach to run a 3x2 xover design using IV dipyrone to calculate absolute bioavailability? or I have to administrate 1500mg (3 and 5 tablets) to the volunteers in a classic 2x2 xover design.

Thank you very much

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