A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects (GLA5PR-101)
|ClinicalTrials.gov Identifier: NCT01635751|
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : January 28, 2013
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 once-a-day formulation which is made by GL Pharm Tech corporation.
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)".
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Pregabalin||Phase 1|
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 malabsorption 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
|Experimental: GLA5PR GLARS tablet 150mg(fasted)||
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
|Experimental: GLA5PR GLARS tablet 150mg(after high fat meal)||
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
|Active Comparator: Lyrica Capsule 75mg(fasted)||
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
- Cmax [ Time Frame: 36hrs ]Pharmacokinetic of Pregabalin
- Tmax [ Time Frame: 36hrs ]Pharmacokinetic of Pregabalin
- AUC0-36h [ 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 of Pregabalin
- T1/2 [ Time Frame: 36hrs ]Pharmacokinetic of Pregabalin
- Safety Monitoring [ Time Frame: 23 days ]Adverse Event, Vital sign, 12-lead ECG, Laboratory test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635751
|Korea, Republic of|
|The Catholic University of Korea, Seoul St.Mary's Hospital|
|Seochogu, Seoul, Korea, Republic of, 137-701|
|Principal Investigator:||Dong-seok Yim||The Catholic University of Korea|