An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.

Detailed Description
-----------------
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

Official Title
-----------------
An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered At Lunch Following Various Caloric Intakes As Compared To The Immediate Release Formulation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories
* Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories
* Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories
* Drug: Pregabalin immediate release, 300 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin controlled release, 330 mg, 400 to 500 calories<br> | Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories<br>* A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch<br>|
| Experimental: Pregabalin controlled release, 330 mg, 600 to 750 calories<br> | Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories<br>* A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch<br>|
| Experimental: Pregabalin controlled release, 330 mg, 800 to 1000 calories<br> | Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories<br>* A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch<br>|
| Other: Pregabalin immediate release, 300 mg<br>Reference | Drug: Pregabalin immediate release, 300 mg<br>* A single oral dose of 300 mg immediate release capsule administered fasted<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregabalin, pharmacokinetics, bioavailability, bioequivalence