Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation

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) while multiple dosing.

Official Title
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A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation After Multiple Dosing Under Fasted Condition in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Immediate release capsule(lyrica 150mg * 2/day)
* Drug: sustained release tablet


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(lyrica capsule 150mg)<br>Immediate release capsule repeat treatment for 3days under fasted condition | Drug: Immediate release capsule(lyrica 150mg * 2/day)<br>* Immediate release capsule<br>|
| Experimental: sustained release tablet<br>sustained release tablet repeat treatment for 3days under fasted condition | Drug: sustained release tablet<br>* sustained release tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure blood concentration of pregabalin |  | 0 4day / 14 18day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation |  | 0 25day | 

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