An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule

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 multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.

Official Title
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An Open-Label, Multiple-Dose, Randomized, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal As Compared To The Immediate Release Formulation

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pregabalin controlled release, 82.5 mg
* Drug: Pregabalin controlled release, 165 mg
* Drug: Pregabalin controlled release, 330 mg
* Drug: Pregabalin immediate release, 150 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, 82.5 mg<br> | Drug: Pregabalin controlled release, 82.5 mg<br>* 82.5 mg controlled release tablet administered once daily for three days.<br>|
| Experimental: Pregabalin controlled release, 165 mg<br> | Drug: Pregabalin controlled release, 165 mg<br>* 165 mg controlled release tablet administered once daily for three days.<br>|
| Experimental: Pregabalin controlled release, 330 mg<br> | Drug: Pregabalin controlled release, 330 mg<br>* 330 mg controlled release tablet administered once daily for three days.<br>|
| Other: Pregabalin immediate release, 150 mg<br>Reference Treatment | Drug: Pregabalin immediate release, 150 mg<br>* 150 mg immediate release capsules administered every 12 hours for three days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ |  | 5 days | 
| Minimum plasma concentration at steady-state within a dosing interval (Cmin) |  | 5 days | 
| Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax) |  | 5 days | 
| The average plasma concentration at steady-state (Cav), half-life |  | 5 days | 
| Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS) |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints include evaluation of adverse events. |  | 5 days | 

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