Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02327000
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 300mg 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers
Study Start Date : October 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Experimental: GLA5PR GLARS-NF1 tablet 150mg
GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day, after meal)
Drug: Pregabalin 150mg
GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
Other Name: GLA5PR GLARS-NF1 tablet 150mg

Experimental: GLA5PR GLARS-NF1 tablet 300mg
GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day, after meal)
Drug: Pregabalin 300mg
GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day)
Other Name: GLA5PR GLARS-NF1 tablet 300mg

Experimental: GLA5PR GLARS-NF1 tablet 450mg
GLA5PR GLARS-NF1 tablet 450mg/day(Pregabalin 150mg 1 tablet and Pregabalin 300mg 1 tablet, 1 times a day, after meal)
Drug: Pregabalin 150mg
GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
Other Name: GLA5PR GLARS-NF1 tablet 150mg

Drug: Pregabalin 300mg
GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day)
Other Name: GLA5PR GLARS-NF1 tablet 300mg

Experimental: GLA5PR GLARS-NF1 tablet 600mg
GLA5PR GLARS-NF1 tablet 600mg/day(Pregabalin 300mg, 2 tablets 1 times a day, after meal)
Drug: Pregabalin 300mg
GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day)
Other Name: GLA5PR GLARS-NF1 tablet 300mg




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

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 19~45 years old, Healthy Adult Male Subject
  • 17.5~30.5kg/m2(BMI) and ≥ 40kg(Body Weight)

Exclusion Criteria:

  • SBP ≥ 140mmHg or DBP ≥ 90mmHg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT02327000    
Other Study ID Numbers: GLA5PR-104
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
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