Bioequivalence Study Summary9
- 61 mg tafamidis free acid capsules were demonstrated to be bioequivalent to 80 mg [4 x 20 mg] tafamidis meglumine capsules at steady-state
- Met the predefined 90% confidence interval criteria of 80% - 125% bioequivalence limits for tafamidis AUC and Cmax, after oral daily dosing for 7 days
- The two formulations, containing the active moiety, are not interchangeable on a per mg basis
AE: adverse events; AUC: area under the curve; Cmax: maximum serum concentration.
