This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a 330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th period to to estimate and compare the % of dose absorbed versus time profile for the three CR prototype tablets and the CR reference tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
300 mg IR capsule administered in the evening in the fasted state.
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
300 mg IR capsule administered in the evening in the fasted state.
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
300 mg IR capsule administered in the evening in the fasted state.
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
300 mg IR capsule administered in the evening in the fasted state.
Pfizer Investigational Site
Brussels, Belgium
Area under plasma concentration-time curve from time zero extrapolated to infinite time (AUClast)
Time frame: predose to 48hr post dose
Area under plasma concentration-time profile from time zero to time of last quantifiable concentration (AUCinf)
Time frame: predose to 48hr post dose
Maximum observed concentration within dosing interval (Cmax)
Time frame: predose to 48hr post dose
Time for Cmax Tmax
Time frame: predose to 48hr post dose
Terminal half-life (t1/2)
Time frame: predose to 48hr post dose
Safety endpoints will be evaluated by comparing the incidence and severity of AEs for each of the formulations evaluated
Time frame: predose to 48hr post dose
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