2 different formulations and 4 different single doses of tafamidis will be compared. All subjects will receive both formulations and 3 different doses. Subjects will be fasted before taking the drug. After swallowing single dose of tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After another 16 days, all subjects will repeat the procedure twice, each time with the other formulation/dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
9
bioavailability study
Pfizer Clinical Research Unit
Brussels, Belgium
1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time (AUCinf)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
2. Maximum Observed Plasma Concentration (Cmax)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
1. Area under the plasma concentration-time profile from time 0 to 24 hours post-dose (AUC24)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
2. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
3. Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
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