PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects (GLA5PR-102)
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)".
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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|
- Cmax.ss [ Time Frame: 36hrs ]Pharmacokinetic of Pregabalin
- AUCtau [ Time Frame: 36hrs ]Pharmacokinetic of Pregabalin
- Safety Monitoring [ Time Frame: 25 days ]Adverse Event, Vital sign, Physical Exam, Laboratory Findings
- Tmax [ Time Frame: 36hrs ]Pharmacokinetic of Pregabalin
- AUC0-∞ [ Time Frame: 36hrs ]Pharmacokinetic of Pregabalin
- CL/F [ Time Frame: 36hrs ]Pharmacokinetic of Pregabalin
- Vd/F [ Time Frame: 36hrs ]Pharmacokinetic parameter of Pregabalin
- T1/2 [ Time Frame: 36hrs ]Pharmacokinetic parameter of Pregabalin
|Study Start Date:||February 2014|
|Study Completion Date:||November 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: GLA5PR GLARS tablet 150mg(mealed)
Drug: Pregabalin 150mg
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days
Other Name: GLA5PR GLARS tablet 150mg
Active Comparator: Lyrica Capsule 75mg(mealed)
Drug: Pregabalin 75mg
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
Other Name: Lyrica Capsule 75mg
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638273
|Korea, Republic of|
|Chonbuk National University Hospital|
|Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712|
|Principal Investigator:||Min-Gul Kim, MD, Ph.D.||Chonbuk National University Hospital|