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

Study Overview
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Brief Summary
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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.

Detailed Description
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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
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pregabalin controlled release, 330 mg, low-fat
* Drug: Pregabalin controlled release, 330 mg, medium-fat
* Drug: Pregabalin controlled release, 330 mg, high-fat
* Drug: Pregabalin immediate release, 300 mg


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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, low-fat<br> | Drug: Pregabalin controlled release, 330 mg, low-fat<br>* A single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal<br>|
| Experimental: Pregabalin controlled release, 330 mg, medium-fat<br> | Drug: Pregabalin controlled release, 330 mg, medium-fat<br>* A single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal<br>|
| Experimental: Pregabalin controlled release, 330 mg, high-fat<br> | Drug: Pregabalin controlled release, 330 mg, high-fat<br>* A single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal<br>|
| Other: Pregabalin immediate release, 300 mg<br>Reference Treatment | Drug: Pregabalin immediate release, 300 mg<br>* A single oral dose of 300 mg immediate release capsule administered following a medium-fat evening meal<br>|

What is the study measuring?
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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
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Keywords Provided by Centre Hospitalier Valida
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pregabalin, pharmacokinetics, bioavailability, bioequivalence