The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
82.5 mg controlled release tablet administered once daily for three days.
165 mg controlled release tablet administered once daily for three days.
330 mg controlled release tablet administered once daily for three days.
150 mg immediate release capsules administered every 12 hours for three days
Pfizer Investigational Site
Brussels, Belgium
Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ
Time frame: 5 days
Minimum plasma concentration at steady-state within a dosing interval (Cmin)
Time frame: 5 days
Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)
Time frame: 5 days
The average plasma concentration at steady-state (Cav), half-life
Time frame: 5 days
Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)
Time frame: 5 days
Safety endpoints include evaluation of adverse events.
Time frame: 5 days
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