An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two 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 two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two 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 two pregabalin controlled release tablets 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 two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule

Official Title
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An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 165 Mg And 330 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal And 150 Mg Of The Immediate Release Formulation Administered Twice Daily

Conditions
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Healthy

Intervention / Treatment
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* 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, 165 mg<br> | Drug: Pregabalin controlled release, 165 mg<br>* Two tablets of 165 mg controlled release (administered concurrently) once daily for four 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 four 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 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 and 150 mg IR (total daily dose 300 mg) |  | 5 days | 
| AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 165 mg CR (two tablets administered concurrently) and 330 mg CR |  | 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