The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Commercial Fesoterodine ER 4 mg (single dose)
Fesoterodine SR3 4 mg (single dose)
Fesoterodine SR3 4 mg (single dose) with high-fat meal
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce
Commercial Fesoterodine ER 4 mg (single dose)
Fesoterodine SR4 4 mg (single dose)
Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce
Pfizer Clinical Research Unit
Brussels, Belgium
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Time frame: 48 hours
Maximum Observed Plasma Concentration (Cmax)
Time frame: 48 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 48 hours
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 48 hours
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