PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).

Detailed Description
-----------------
Basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously. The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. This serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for mal-absorption of a drug in colon. As the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release. At virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release. This relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.

Official Title
-----------------
A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg and Immediate Release Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Pregabalin 150mg
* Drug: Pregabalin 75mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 45 years old, Healthy Adult Male Subject ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20% Exclusion Criteria: ALT or AST > 1.25(Upper Normal Range) Total Bilirubin > 1.5 (Upper Normal Range)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLA5PR GLARS tablet 150mg(mealed)<br>Pregabalin 150mg | Drug: Pregabalin 150mg<br>* GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days<br>* Other names: GLA5PR GLARS tablet 150mg;|
| Active Comparator: Lyrica Capsule 75mg(mealed)<br>Pregabalin 75mg | Drug: Pregabalin 75mg<br>* Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days<br>* Other names: Lyrica Capsule 75mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax.ss | Pharmacokinetic of Pregabalin | 36hrs | 
| AUCtau | Pharmacokinetic of Pregabalin | 36hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Monitoring | Adverse Event, Vital sign, Physical Exam, Laboratory Findings | 25 days | 
| Tmax | Pharmacokinetic of Pregabalin | 36hrs | 
| AUC0-∞ | Pharmacokinetic of Pregabalin | 36hrs | 
| CL/F | Pharmacokinetic of Pregabalin | 36hrs | 
| Vd/F | Pharmacokinetic parameter of Pregabalin | 36hrs | 
| T1/2 | Pharmacokinetic parameter of Pregabalin | 36hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregabalin, GLARS