An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:9/30/2018
Start Date:March 2011
End Date:April 2011

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of A Low, Medium And High Fat Evening Meal 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 tablet following either a low, medium, or high-fat evening meal
as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the
safety and tolerability of a single dose of a pregabalin controlled release tablet following
a low, medium, or high fat evening meal 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

Inclusion Criteria:

- Healthy male or females

- Between the ages of 18 and 55 years, inclusive

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

- Illicit drug use

- Pregnant or nursing females

- Females of childbearing potential who are unwilling or unable to use an acceptable
method of contraception
We found this trial at
1
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Pfizer Investigational Site
Overland Park, Kansas 66215
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Overland Park, KS
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