A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation

Study Overview
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Brief Summary
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The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.

Detailed Description
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To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: 330 mg pregabalin controlled release
* Drug: 330 mg pregabalin controlled release
* Drug: 330 mg pregabalin controlled release
* Drug: 300 mg pregabalin immediate release


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: 330 mg pregabalin controlled release: 400 to 500 calories<br> | Drug: 330 mg pregabalin controlled release<br>* A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal<br>|
| Experimental: 330 mg pregabalin controlled release: 600 to 750 calories<br> | Drug: 330 mg pregabalin controlled release<br>* A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal<br>|
| Experimental: 330 mg pregabalin controlled release: 800 to 1000 calories<br> | Drug: 330 mg pregabalin controlled release<br>* A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal<br>|
| Other: 300 mg pregabalin immediate release<br> | Drug: 300 mg pregabalin immediate release<br>* A single dose of 300 mg immediate release capsule will be administered in the fasted state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf) |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, vital signs, and clinical safety laboratories. |  | 3 days | 

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