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

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.

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)