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
NCT ID: NCT01635751
Last Updated: 2013-01-28
Study Results
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Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2012-10-31
2012-11-30
Brief Summary
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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)".
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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GLA5PR GLARS tablet 150mg(fasted)
Pregabalin
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
GLA5PR GLARS tablet 150mg(after high fat meal)
Pregabalin
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
Lyrica Capsule 75mg(fasted)
Pregabalin
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
Interventions
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Pregabalin
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
Pregabalin
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
Pregabalin
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
Eligibility Criteria
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Inclusion Criteria
* ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
Exclusion Criteria
* Total Bilirubin \> 1.5 (Upper Normal Range)
20 Years
45 Years
MALE
Yes
Sponsors
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GL Pharm Tech Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Dong-seok Yim
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
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The Catholic University of Korea, Seoul St.Mary's Hospital
Seochogu, Seoul, South Korea
Countries
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Other Identifiers
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GLA5PR-101
Identifier Type: -
Identifier Source: org_study_id
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