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

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 (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.

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 Caloric Content And Time Of Dosing 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, 400 to 500 calorie
* Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie
* Drug: Pregabalin controlled release, 330 mg, bedtime
* 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, 400-500 calorie<br> | Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie<br>* A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal<br>|
| Experimental: Pregabalin controlled release, 330 mg, 600- 750 calorie<br> | Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie<br>* A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal<br>|
| Experimental: Pregabalin controlled release, 330 mg, bedtime<br> | Drug: Pregabalin controlled release, 330 mg, bedtime<br>* A single oral dose of 330 mg controlled release tablet administered at bedtime<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 in the evening<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