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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

NCT ID: NCT02326987

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-11-30

Brief Summary

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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)".

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GLA5PR GLARS-NF1 tab.150mg(fasted)

GLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day)

Group Type EXPERIMENTAL

Pregabalin 150mg

Intervention Type DRUG

GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)

GLA5PR GLARS-NF1 tab.150mg(after high fat meal)

GLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day)

Group Type EXPERIMENTAL

Pregabalin 150mg

Intervention Type DRUG

GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)

Lyrica Capsule 75mg(after high fat meal)

Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)

Group Type ACTIVE_COMPARATOR

Pregabalin 75mg

Intervention Type DRUG

Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)

Interventions

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Pregabalin 150mg

GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)

Intervention Type DRUG

Pregabalin 75mg

Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)

Intervention Type DRUG

Other Intervention Names

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GLA5PR GLARS-NF1 tab.150mg Lyrica Capsule 75mg

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GL Pharm Tech Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Kim TE, Jeon JY, Gu N, Chang Kwon M, Kim MG. Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2112-2124. doi: 10.1016/j.clinthera.2018.10.017. Epub 2018 Nov 27.

Reference Type DERIVED
PMID: 30497798 (View on PubMed)

Other Identifiers

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GLA5PR-103

Identifier Type: -

Identifier Source: org_study_id