Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2011 |
| End Date: | May 2011 |
An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of Caloric Content And Time Of Dosing On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation
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
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