The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime as compared to a single dose of the pregabalin immediate release capsule.
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal
A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal
A single oral dose of 330 mg controlled release tablet administered at bedtime
A single oral dose of 300 mg immediate release capsule administered in the evening
Pfizer Investigational Site
New Haven, Connecticut, United States
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
Time frame: 3 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 days
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