An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The 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 multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Detailed Description
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Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule

Official Title
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An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of 660 Mg (2 X 330 Mg Tablets) Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative To The 300 Mg Of The Immediate Release Formulation Administered Twice Daily

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pregabalin immediate release, 300 mg
* Drug: Pregabalin controlled release, 330 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 |
| --- | --- |
| Other: Pregabalin immediate release, 300 mg<br>Reference Treatment | Drug: Pregabalin immediate release, 300 mg<br>* 300 mg immediate release capsule administered twice daily for four days<br>|
| Experimental: Pregabalin controlled release, 330 mg<br> | Drug: Pregabalin controlled release, 330 mg<br>* Two tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four 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 over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR (two tablets administered concurrently for a total 660 mg dose) and 300 mg IR capsule given 2times daily (total daily dose 600 mg) |  | 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