This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
relative bioavailability
fasted
fed
Pfizer Clinical Research Unit
Brussels, Belgium
Area under the concentration-time Curve (AUC)
Time frame: 120 hours
Maximum Observed Plasma Concentration (Cmax)
Time frame: 120 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 120 hours
Plasma Decay Half-Life (t1/2)
Time frame: 120 hours
Area Under the Curve from Time zero to infinity
Time frame: 120 hours
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