Study for Comparing The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to: Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg * 2). Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.

Official Title
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A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lyrica
* Drug: Experimental drug
* Dietary Supplement: High fat meal
* Dietary Supplement: fasted


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 44 aged healthy adult. someone tho has at least 50kg body weight and ideal body weight ±20% Exclusion Criteria: someone has acute symptom at screening phase someone has any disease or symptoms which is clinically significant someone had been determined during healthy examination in screening period AST or ALT > 1.25 times than normal Total bilirubin > 1.5 times than normal someone who has a history of allergy, anaphylaxis, drug abuse or misuse. someone who had enrolled to other clinical trial within the last 60 days. someone who had donated blood within the last 60 days. someone who can't take a meal derived from this trial. someone who has taken abnormal meals like which can affect to drug ADME someone who has taken other ETC drugs or oriental drugs within the last 14 days, Or OTC drugs within the last 7 days someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before. someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day. someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate release capsule<br>Immediate release capsule treatment under fasted condition | Drug: Lyrica<br> <br> Dietary Supplement: fasted<br> <br> |
| Experimental: sustained release tablet<br>sustained release tablet treatment under fasted condition | Drug: Experimental drug<br>* sustained release formulation of pregabalin<br>Dietary Supplement: fasted<br> <br> |
| Experimental: sustained release tablet (high fat meal)<br>sustained release tablet under high fat meal condition. | Drug: Experimental drug<br>* sustained release formulation of pregabalin<br>Dietary Supplement: High fat meal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUC of pregabalin |  | 0 36h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation |  | 0 24day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, pregabalin