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

December 23, 2014 updated by: GL Pharm Tech Corporation

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)".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • GLA5PR GLARS-NF1 tablet 150mg
Drug: Pregabalin 300mg
GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day)
Other Names:
  • 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 Names:
  • GLA5PR GLARS-NF1 tablet 300mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUClast
Time Frame: 36hrs
Pharmacokinetic of Pregabalin
36hrs
Cmax
Time Frame: 36hrs
Pharmacokinetic of Pregabalin
36hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf
Time Frame: 36hrs
Pharmacokinetic of Pregabalin
36hrs
Tmax
Time Frame: 36hrs
Pharmacokinetic of Pregabalin
36hrs
t1/2
Time Frame: 36hrs
Pharmacokinetic of Pregabalin
36hrs
CL/F
Time Frame: 36hrs
Pharmacokinetic of Pregabalin
36hrs
Vd/F
Time Frame: 36hrs
Pharmacokinetic of Pregabalin
36hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GL Pharm Tech Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLA5PR-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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