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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation
ClinicalTrials.gov Identifier:
NCT01635751
First received: July 4, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes

July 4, 2012
January 25, 2013
October 2012
November 2012   (final data collection date for primary outcome measure)
  • Cmax [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
  • Tmax [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
  • AUC0-36h [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
  • AUC0-∞ [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
  • CL/F [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
  • Vd/F [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
  • T1/2 [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
Same as current
Complete list of historical versions of study NCT01635751 on ClinicalTrials.gov Archive Site
Safety Monitoring [ Time Frame: 23 days ] [ Designated as safety issue: Yes ]
Adverse Event, Vital sign, 12-lead ECG, Laboratory test
Safety Monitoring [ Time Frame: 23 days ] [ Designated as safety issue: Yes ]
Adverse Event, Vital sign, Physical Exam, Laboratory Findings
Not Provided
Not Provided
 
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
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

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)".

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: Pregabalin
    GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
  • Drug: Pregabalin
    GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
  • Drug: Pregabalin
    Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
  • Experimental: GLA5PR GLARS tablet 150mg(fasted)
    Intervention: Drug: Pregabalin
  • Experimental: GLA5PR GLARS tablet 150mg(after high fat meal)
    Intervention: Drug: Pregabalin
  • Active Comparator: Lyrica Capsule 75mg(fasted)
    Intervention: Drug: Pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2012
November 2012   (final data collection date for primary outcome measure)

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)
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01635751
GLA5PR-101
No
GL Pharm Tech Corporation
GL Pharm Tech Corporation
Not Provided
Principal Investigator: Dong-seok Yim The Catholic University of Korea Seoul St.Mary's Hospital
GL Pharm Tech Corporation
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP