The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.
To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal
A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal
A single dose of 300 mg immediate release capsule will be administered in the fasted state
Pfizer Investigational Site
New Haven, Connecticut, United States
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
Time frame: 3 days
Adverse events, vital signs, and clinical safety laboratories.
Time frame: 3 days
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