Bioequivalence and Bioavailability Forum

We are working on this molecule, and would like to establish bioequivalence for 1 mg and 0.5 mg tablets versus the reference drug product available in UK and South Africa.

We find this drug has a complicated pharmacokinetics with a short half, low dose, highly biovariable with biliary excretion, and bioavailability of 25-50%. We do not have the data on intrasubject coefficient of variation from the literature. We would appreciate if someone could guide us regarding the number of volunteers to assess the bioequivalence of Colchicine Tablets 0.5 mg, 1mg. Also, will appreciate performance in fed and fasted condition.