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A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02326987
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: Pregabalin 150mg Drug: Pregabalin 75mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Open, Single-dose, 3-treatment, 3-period, 6-sequence Crossover Study in Healthy Male Subjects to Evaluate the Pharmacokinetics of GLA5PR GLARS-NF1 Tablet 150mg and LYRICA® Capsule 75mg
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013


Arm Intervention/treatment
Experimental: GLA5PR GLARS-NF1 tab.150mg(fasted)
GLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day)
Drug: Pregabalin 150mg
GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
Other Name: GLA5PR GLARS-NF1 tab.150mg

Experimental: GLA5PR GLARS-NF1 tab.150mg(after high fat meal)
GLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day)
Drug: Pregabalin 150mg
GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
Other Name: GLA5PR GLARS-NF1 tab.150mg

Active Comparator: Lyrica Capsule 75mg(after high fat meal)
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)
Drug: Pregabalin 75mg
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)
Other Name: Lyrica Capsule 75mg




Primary Outcome Measures :
  1. AUClast [ Time Frame: 36hrs ]
    Pharmacokinetic of Pregabalin

  2. Cmax [ Time Frame: 36hrs ]
    Pharmacokinetic of Pregabalin


Secondary Outcome Measures :
  1. AUCinf [ Time Frame: 36hrs ]
    Pharmacokinetic of Pregabalin

  2. Tmax [ Time Frame: 36hrs ]
    Pharmacokinetic of Pregabalin

  3. t1/2 [ Time Frame: 36hrs ]
    Pharmacokinetic of Pregabalin

  4. CL/F [ Time Frame: 36hrs ]
    Pharmacokinetic of Pregabalin

  5. Vd/F [ Time Frame: 36hrs ]
    Pharmacokinetic of Pregabalin



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20~45 years old, Healthy Adult Male Subject
  • 17.5~30.5kg/m2(BMI) and ≥ 45kg

Exclusion Criteria:

  • SBP ≥ 140mmHg or DBP ≥ 90mmHg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT02326987    
Other Study ID Numbers: GLA5PR-103
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs