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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
  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 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)".


Condition Intervention Phase
Healthy
Drug: Pregabalin 150mg
Drug: Pregabalin 75mg
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, 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

Resource links provided by NLM:


Further study details as provided by GL Pharm Tech Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 24
Study Start Date: February 2014
Study Completion Date: November 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLA5PR GLARS tablet 150mg(mealed)
Pregabalin 150mg
Drug: Pregabalin 150mg
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days
Other Name: GLA5PR GLARS tablet 150mg
Active Comparator: Lyrica Capsule 75mg(mealed)
Pregabalin 75mg
Drug: Pregabalin 75mg
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
Other Name: Lyrica Capsule 75mg

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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638273

Locations
Korea, Republic of
Chonbuk National University Hospital
Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
Sponsors and Collaborators
GL Pharm Tech Corporation
Investigators
Principal Investigator: Min-Gul Kim, MD, Ph.D. Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT01638273     History of Changes
Other Study ID Numbers: GLA5PR-102
Study First Received: July 9, 2012
Last Updated: November 11, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by GL Pharm Tech Corporation:
Pregabalin, GLARS

Additional relevant MeSH terms:
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014