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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
  Purpose

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 Intervention Phase
Healthy
 Drug: Pregabalin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by GL Pharm Tech Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Safety Monitoring [ Time Frame: 23 days ] [ Designated as safety issue: Yes ]
    Adverse Event, Vital sign, 12-lead ECG, Laboratory test


Enrollment: 30
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLA5PR GLARS tablet 150mg(fasted) Drug: Pregabalin
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
Experimental: GLA5PR GLARS tablet 150mg(after high fat meal) Drug: Pregabalin
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
Active Comparator: Lyrica Capsule 75mg(fasted) Drug: Pregabalin
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635751

Locations
Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
Seochogu, Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
GL Pharm Tech Corporation
Investigators
Principal Investigator: Dong-seok Yim The Catholic University of Korea Seoul St.Mary's Hospital
  More Information

No publications provided

Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT01635751     History of Changes
Other Study ID Numbers: GLA5PR-101
Study First Received: July 4, 2012
Last Updated: January 25, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by GL Pharm Tech Corporation:
Pregabalin
GLARS

Additional relevant MeSH terms:
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 19, 2013