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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 (GLA5PR-102)

This study is not yet open for participant recruitment.
Verified July 2012 by GL Pharm Tech Corporation
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation
ClinicalTrials.gov Identifier:
NCT01638273
First received: July 9, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes

July 9, 2012
July 10, 2012
May 2013
June 2013   (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 NCT01638273 on ClinicalTrials.gov Archive Site
Safety Monitoring [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]
Adverse Event, Vital sign, Physical Exam, Laboratory Findings
Same as current
Not Provided
Not Provided
 
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
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

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)".

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.
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, after meal) for three days
  • Drug: Pregabalin
    Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
  • Experimental: GLA5PR GLARS tablet 150mg(mealed)
    Intervention: Drug: Pregabalin
  • Active Comparator: Lyrica Capsule 75mg(mealed)
    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.
 
Not yet recruiting
24
July 2013
June 2013   (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
Not Provided
Korea, Republic of
 
NCT01638273
GLA5PR-102
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
July 2012

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