PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects (GLA5PR-102)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation
ClinicalTrials.gov Identifier:
NCT01638273
First received: July 9, 2012
Last updated: November 11, 2014
Last verified: November 2014

July 9, 2012
November 11, 2014
February 2014
July 2014   (final data collection date for primary outcome measure)
  • Cmax.ss [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
  • AUCtau [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic of Pregabalin
  • 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
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
  • Tmax [ 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 parameter of Pregabalin
  • T1/2 [ Time Frame: 36hrs ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter of Pregabalin
Safety Monitoring [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]
Adverse Event, Vital sign, Physical Exam, Laboratory Findings
Not Provided
Not Provided
 
PK Study of Pregabalin GLARS Tablet 150mg and IR 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 150mg
    GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days
    Other Name: GLA5PR GLARS tablet 150mg
  • Drug: Pregabalin 75mg
    Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
    Other Name: Lyrica Capsule 75mg
  • Experimental: GLA5PR GLARS tablet 150mg(mealed)
    Pregabalin 150mg
    Intervention: Drug: Pregabalin 150mg
  • Active Comparator: Lyrica Capsule 75mg(mealed)
    Pregabalin 75mg
    Intervention: Drug: Pregabalin 75mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2014
July 2014   (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
 
NCT01638273
GLA5PR-102
No
GL Pharm Tech Corporation
GL Pharm Tech Corporation
Not Provided
Principal Investigator: Min-Gul Kim, MD, Ph.D. Chonbuk National University Hospital
GL Pharm Tech Corporation
November 2014

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